Clinical trial: NCT02154490
Section: Alternatives
Subsections: What Is The Usual Approach To My Lung Cancer?|What Is The Usual Approach To My Lung Cancer?|What Are My Other Choices If I Do Not Take Part In This Study?|What Are My Other Choices If I Do Not Take Part In This Study?|What Is The Usual Approach To My Lung Cancer?|What Is The Usual Approach To My Lung Cancer?|What Are My Other Choices If I Do Not Take Part In This Study?|What Are My Other Choices If I Do Not Take Part In This Study?

Squamous cell lung cancers make up about one-fourth of non-small cell lung cancers. Various chemotherapy drugs have been shown to improve survival for patients with advanced squamous cell lung cancer. Most patients, for example, will be treated at first with cisplatin or carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel, docetaxel, or vinorelbine. In addition, immunotherapy has been recently FDA approved for patients with previously untreated squamous cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.

Squamous cell lung cancers make up about one-fourth of non-small cell lung cancer. Various chemotherapy drugs have been shown to improve survival for patients with advanced squamous cell lung cancer. Most patients, for example, will be treated at first with cisplatin or carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel, docetaxel, or vinorelbine. In addition, immunotherapy has been recently FDA approved for patients with previously untreated squamous cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.

If you decide not to take part in this study, you have other choices. For example:
- You may choose to have the usual approach described above - You may choose to take part in a different study, if one is available
- Or you could decide not to be treated for cancer, but you may want to get comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

If you decide not to take part in this study, you have other choices. For example:
- You may choose to have the usual approach described above - You may choose to take part in a different study, if one is available
- Or you could decide not to be treated for cancer, but you may want to get comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

Squamous cell lung cancers make up about one-fourth of non-small cell lung cancers. Various chemotherapy drugs have been shown to improve survival for patients with advanced squamous cell lung cancer. Most patients, for example, will be treated at first with cisplatin or carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel, docetaxel, or vinorelbine. In addition, immunotherapy has been recently FDA approved for patients with previously untreated squamous cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.

Squamous cell lung cancers make up about one-fourth of non-small cell lung cancer. Various chemotherapy drugs have been shown to improve survival for patients with advanced squamous cell lung cancer. Most patients, for example, will be treated at first with cisplatin or carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel, docetaxel, or vinorelbine. In addition, immunotherapy has been recently FDA approved for patients with previously untreated squamous cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.

If you decide not to take part in this study, you have other choices. For example:
- You may choose to have the usual approach described above - You may choose to take part in a different study, if one is available
- Or you could decide not to be treated for cancer, but you may want to get comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

If you decide not to take part in this study, you have other choices. For example:
- You may choose to have the usual approach described above - You may choose to take part in a different study, if one is available
- Or you could decide not to be treated for cancer, but you may want to get comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Clinical trial: NCT02154490
Section: Confidentiality
Subsections: Who Will See My Medical Information?|Who Will See My Medical Information?|How Will Information About Me Be Kept Private?|How Will Information About Me Be Kept Private?|Will My Name Be Attached To The Records That Are Given To The Researcher?|Will My Name Be Attached To The Records That Are Given To The Researcher?|How Am I Protected?|How Am I Protected?|Who Will See My Medical Information?|Who Will See My Medical Information?|How Will Information About Me Be Kept Private?|How Will Information About Me Be Kept Private?|Will My Name Be Attached To The Records That Are Given To The Researcher?|Will My Name Be Attached To The Records That Are Given To The Researcher?|How Am I Protected?|How Am I Protected?

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make  
 sure your information is kept private, unless required by law to provide information. Some of these organizations are:
- The study sponsor, SWOG, and the drug and device companies supporting the study.  
- The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make  
 sure your information is kept private, unless required by law to provide information. Some of these organizations are:
- The study sponsor, SWOG, and the drug and device companies supporting the study.  
- The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
1) When your samples are sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law. 5) If research results are published, your name and other personal information will not be used.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
1) When your samples are sent to the researchers, no information identifying you
(such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law.  
5) If research results are published, your name and other personal information will not be used.

No. Your name, address, phone number and anything else that could identify you will be removed before  
  
they go to the researcher. The researcher will not know who you are.

No. Your name, address, phone number and anything else that could identify you will be removed before  
  
they go to the researcher. The researcher will not know who you are.

SWOG is in charge of making sure that information about you is kept private. SWOG will take careful steps to prevent misuse of records. Your name, address, phone number and any other identifying information will be taken off anything associated with your specimen before it is given to the researcher. This would make it very difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.

SWOG is in charge of making sure that information about you is kept private. SWOG will take careful steps to prevent misuse of records. Your name, address, phone number and any other identifying information will be taken off anything associated with your specimen before it is given to the researcher. This would make it very difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make  
 sure your information is kept private, unless required by law to provide information. Some of these organizations are:
- The study sponsor, SWOG, and the drug and device companies supporting the study.  
- The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make  
 sure your information is kept private, unless required by law to provide information. Some of these organizations are:
- The study sponsor, SWOG, and the drug and device companies supporting the study.  
- The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
1) When your samples are sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law. 5) If research results are published, your name and other personal information will not be used.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:
1) When your samples are sent to the researchers, no information identifying you
(such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.  
4) Information that identifies you will not be given to anyone, unless required by law.  
5) If research results are published, your name and other personal information will not be used.

No. Your name, address, phone number and anything else that could identify you will be removed before  
  
they go to the researcher. The researcher will not know who you are.

No. Your name, address, phone number and anything else that could identify you will be removed before  
  
they go to the researcher. The researcher will not know who you are.

SWOG is in charge of making sure that information about you is kept private. SWOG will take careful steps to prevent misuse of records. Your name, address, phone number and any other identifying information will be taken off anything associated with your specimen before it is given to the researcher. This would make it very difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.

SWOG is in charge of making sure that information about you is kept private. SWOG will take careful steps to prevent misuse of records. Your name, address, phone number and any other identifying information will be taken off anything associated with your specimen before it is given to the researcher. This would make it very difficult for any research results to be linked to you or your family. Also, people outside the research process will not have access to results about any one person which will help to protect your privacy.
Clinical trial: NCT02154490
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?|How Long Will I Be In This Study?|How Long Will I Be In This Study?|How Long Will I Be In This Study?

The amount of time you will be on treatment depends on which sub-study you are in and how your disease responds to treatment. The screening step will take approximately two weeks from the time your tumor is shipped to the laboratory for examination. Even if you do not take part in any of the sub-studies for treatment, your study doctor will check your health status for this study every six months for up to three years.

The amount of time for the pre-screening step will depend on if and when your tumor begins to grow. The amount of time you will be on treatment depends on which sub-study you are in and how your disease responds to treatment. Even if you do not take part in any of the sub-studies for treatment, your study doctor will check your health status for this study every six months for up to three years.

The amount of time you will be on treatment depends on which sub-study you are in and how your disease responds to treatment. The screening step will take approximately two weeks from the time your tumor is shipped to the laboratory for examination. Even if you do not take part in any of the sub-studies for treatment, your study doctor will check your health status for this study every six months for up to three years.

The amount of time for the pre-screening step will depend on if and when your tumor begins to grow. The amount of time you will be on treatment depends on which sub-study you are in and how your disease responds to treatment. Even if you do not take part in any of the sub-studies for treatment, your study doctor will check your health status for this study every six months for up to three years.
Clinical trial: NCT02154490
Section: Participant's Rights
Subsections: What Are My Rights In This Study?|What Are My Rights In This Study?|What Are My Rights In This Study?|What Are My Rights In This Study?

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ *(insert* name of center) Institutional Review Board at __________________ (insert telephone number). (Note to Local Investigator: Contact information for patient representatives or other individuals  
 at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ (insert name of center) Institutional Review Board at __________________ (insert telephone number). (Note to Local Investigator: Contact information for patient representatives or other individuals  
 at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ *(insert* name of center) Institutional Review Board at __________________ (insert telephone number). (Note to Local Investigator: Contact information for patient representatives or other individuals  
 at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, call the ________________________ (insert name of center) Institutional Review Board at __________________ (insert telephone number). (Note to Local Investigator: Contact information for patient representatives or other individuals  
 at a local institution who are not on the IRB or research team but take calls regarding clinical trial questions can also be listed here.)
Clinical trial: NCT02154490
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Possible Risks Can I Expect From Taking Part In The Screening Part Of This Study?|What Possible Risks Can I Expect From Taking Part In The Screening Part Of This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Are The Possible Risks?|What Are The Possible Risks?|What Are The Possible Benefits?|What Are The Possible Benefits?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|How Could The Records Be Used In Ways That Might Be Harmful To Me?|How Could The Records Be Used In Ways That Might Be Harmful To Me?|What Possible Risks Can I Expect From Taking Part In The Screening Part Of This Study?|What Possible Risks Can I Expect From Taking Part In The Screening Part Of This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|What Possible Benefits Can I Expect From Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Are The Possible Risks?|What Are The Possible Risks?|What Are The Possible Benefits?|What Are The Possible Benefits?|Are There Any Costs Or Payments?|Are There Any Costs Or Payments?|How Could The Records Be Used In Ways That Might Be Harmful To Me?|How Could The Records Be Used In Ways That Might Be Harmful To Me?

If you choose to take part in the screening part of this study, there is a risk that:  
  
- As with all medical screening tests, there is a chance of a false positive or a false negative result. A "false positive" refers to the identification of a biomarker that is not present. A "false negative" is the failure to find a biomarker that indeed exists. The tests have been designed to ensure that the possibility of incorrect results is low. Either a false positive or a false negative test would mean that your treatment assignment would not include the correct targeted treatment. However, because we do not know whether targeted treatment will work for you, we cannot say whether an incorrect treatment assignment would be worse.  
- If you have to have another biopsy to get more tissue, you may have bleeding or infection. You may have pain and bruising at the biopsy site, which can be treated with regular pain medication. Also, you may have the biopsy and still not have enough tissue to go on the study. Rarely, patients may experience partial lung collapse that may require a chest tube or even a breathing machine.  
- You may lose time at work or home and spend more time in the hospital or doctor's office than usual.  
- You may be asked sensitive or private questions which you normally do not discuss.  
- There is a risk someone could get access to the personal information in your medical records or other information researchers have kept about you. Someone might be able to trace this information back to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information. In some cases, this information could be used to make it harder for you to get or keep a job. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur. There are laws against misuse of genetic information, but they may not give full protection. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The new law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and long-term care insurance.  
- There can also be a risk in finding out new genetic information about you. New health information about inherited traits that might affect you or your blood relatives could be found during a study.  
Let your study doctor know of any questions you have about possible risks. You can ask the study doctor questions about risks at any time.

If you choose to take part in the pre-screening part of this study, there is a risk that:
- As with all medical screening tests, there is a chance of a false positive or a false negative  
  
result. A "false positive" refers to the identification of a biomarker that is not present. A "false negative" is the failure to find a biomarker that indeed exists. The tests have been designed to ensure that the possibility of incorrect results is low. Either a false positive or a false negative test would mean that your treatment assignment would not include the correct targeted treatment. However, because we do not know whether targeted treatment will work for you, we cannot say whether an incorrect treatment assignment would be worse.  
- If you have to have another biopsy to get more tissue, you may have bleeding or infection. You may have pain and bruising at the biopsy site, which can be treated with regular pain medication. Also, you may have the biopsy and still not have enough tissue to go on the study. Rarely, patients may experience partial lung collapse that may require a chest tube or even a breathing machine.  
- You may lose time at work or home and spend more time in the hospital or doctor's office than usual.  
- You may be asked sensitive or private questions which you normally do not discuss.  
- There is a risk someone could get access to the personal information in your medical records or other information researchers have kept about you. Someone might be able to trace this information back to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information. In some cases, this information could be used to make it harder for you to get or keep a job. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur. There are laws against misuse of genetic information, but they may not give full protection. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The new law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and long-term care insurance.  
- There can also be a risk in finding out new genetic information about you. New health information about inherited traits that might affect you or your blood relatives could be found during a study.  
Let your study doctor know of any questions you have about possible risks. You can ask the study doctor questions about risks at any time.

It is not possible to know at this time if the study approach to genetic screening of your tumor sample to help select treatment drugs is better than the usual approach, so this study may or may not help you. This study will help researchers learn things that will help people in the future.

It is not possible to know at this time if the study approach to genetic screening of your tumor sample to help select treatment drugs is better than the usual approach, so this study may or may not help you. This study will help researchers learn things that will help people in the future.

There is no cost to you or your insurance associated with this screening or if you have to have an extra biopsy to collect more tissue for this screening (the biopsy cost will be provided in this case at a standard rate). However, if testing of your tumor sample shows that you are eligible for one of the treatment studies, you and/or your health plan/insurance company will need to pay for the costs of caring for your cancer while in this treatment study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. Other costs will be addressed in more detail in the consent form for the treatment you are offered. You will not be paid for taking part in this study.

There is no cost to you or your insurance associated with this screening or if you have to have an extra biopsy to collect more tissue for this screening (the biopsy cost will be provided in this case at a standard rate). However, if testing of your tumor sample shows that you are eligible for one of the treatment studies, you and/or your health plan/insurance company will need to pay for the costs of caring for your cancer while in this treatment study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. Other costs will be addressed in more detail in the consent form for the treatment you are offered. You will not be paid for taking part in this study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

1) There is a risk that someone could get access to the personal information in your  
  
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and longterm care insurance. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.

1) There is a risk that someone could get access to the personal information in your  
  
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and longterm care insurance. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.

You will not benefit from taking part. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

You will not benefit from taking part. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

There are no costs to you or your insurance. You will not be paid for taking part. If any of the research leads to new tests, drugs, or other commercial products, you will not share in any profits.

There are no costs to you or your insurance. You will not be paid for taking part. If any of the  
 research leads to new tests, drugs, or other commercial products, you will not share in any profits.

Sometimes, health records have been used against patients and their families. For example, insurance companies may deny a patient insurance or employers may not hire someone with a certain illness (such as AIDS or cancer). The results of genetic research may not apply only to you, but to your family members too. For disease caused by gene changes, the information in one person's health record could be used against family members.

Sometimes, health records have been used against patients and their families. For example, insurance companies may deny a patient insurance or employers may not hire someone with a certain illness (such as AIDS or cancer). The results of genetic research may not apply only to you, but to your family members too. For disease caused by gene changes, the information in one person's health record could be used against family members.

If you choose to take part in the screening part of this study, there is a risk that:  
  
- As with all medical screening tests, there is a chance of a false positive or a false negative result. A "false positive" refers to the identification of a biomarker that is not present. A "false negative" is the failure to find a biomarker that indeed exists. The tests have been designed to ensure that the possibility of incorrect results is low. Either a false positive or a false negative test would mean that your treatment assignment would not include the correct targeted treatment. However, because we do not know whether targeted treatment will work for you, we cannot say whether an incorrect treatment assignment would be worse.  
- If you have to have another biopsy to get more tissue, you may have bleeding or infection. You may have pain and bruising at the biopsy site, which can be treated with regular pain medication. Also, you may have the biopsy and still not have enough tissue to go on the study. Rarely, patients may experience partial lung collapse that may require a chest tube or even a breathing machine.  
- You may lose time at work or home and spend more time in the hospital or doctor's office than usual.  
- You may be asked sensitive or private questions which you normally do not discuss.  
- There is a risk someone could get access to the personal information in your medical records or other information researchers have kept about you. Someone might be able to trace this information back to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information. In some cases, this information could be used to make it harder for you to get or keep a job. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur. There are laws against misuse of genetic information, but they may not give full protection. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The new law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and long-term care insurance.  
- There can also be a risk in finding out new genetic information about you. New health information about inherited traits that might affect you or your blood relatives could be found during a study.  
Let your study doctor know of any questions you have about possible risks. You can ask the study doctor questions about risks at any time.

If you choose to take part in the pre-screening part of this study, there is a risk that:
- As with all medical screening tests, there is a chance of a false positive or a false negative  
  
result. A "false positive" refers to the identification of a biomarker that is not present. A "false negative" is the failure to find a biomarker that indeed exists. The tests have been designed to ensure that the possibility of incorrect results is low. Either a false positive or a false negative test would mean that your treatment assignment would not include the correct targeted treatment. However, because we do not know whether targeted treatment will work for you, we cannot say whether an incorrect treatment assignment would be worse.  
- If you have to have another biopsy to get more tissue, you may have bleeding or infection. You may have pain and bruising at the biopsy site, which can be treated with regular pain medication. Also, you may have the biopsy and still not have enough tissue to go on the study. Rarely, patients may experience partial lung collapse that may require a chest tube or even a breathing machine.  
- You may lose time at work or home and spend more time in the hospital or doctor's office than usual.  
- You may be asked sensitive or private questions which you normally do not discuss.  
- There is a risk someone could get access to the personal information in your medical records or other information researchers have kept about you. Someone might be able to trace this information back to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information. In some cases, this information could be used to make it harder for you to get or keep a job. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur. There are laws against misuse of genetic information, but they may not give full protection. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The new law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and long-term care insurance.  
- There can also be a risk in finding out new genetic information about you. New health information about inherited traits that might affect you or your blood relatives could be found during a study.  
Let your study doctor know of any questions you have about possible risks. You can ask the study doctor questions about risks at any time.

It is not possible to know at this time if the study approach to genetic screening of your tumor sample to help select treatment drugs is better than the usual approach, so this study may or may not help you. This study will help researchers learn things that will help people in the future.

It is not possible to know at this time if the study approach to genetic screening of your tumor sample to help select treatment drugs is better than the usual approach, so this study may or may not help you. This study will help researchers learn things that will help people in the future.

There is no cost to you or your insurance associated with this screening or if you have to have an extra biopsy to collect more tissue for this screening (the biopsy cost will be provided in this case at a standard rate). However, if testing of your tumor sample shows that you are eligible for one of the treatment studies, you and/or your health plan/insurance company will need to pay for the costs of caring for your cancer while in this treatment study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. Other costs will be addressed in more detail in the consent form for the treatment you are offered. You will not be paid for taking part in this study.

There is no cost to you or your insurance associated with this screening or if you have to have an extra biopsy to collect more tissue for this screening (the biopsy cost will be provided in this case at a standard rate). However, if testing of your tumor sample shows that you are eligible for one of the treatment studies, you and/or your health plan/insurance company will need to pay for the costs of caring for your cancer while in this treatment study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for. Other costs will be addressed in more detail in the consent form for the treatment you are offered. You will not be paid for taking part in this study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

1) There is a risk that someone could get access to the personal information in your  
  
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and longterm care insurance. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.

1) There is a risk that someone could get access to the personal information in your  
  
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. The Genetic Information Nondiscrimination Act of 2008, also referred to as GINA, was passed by Congress to protect Americans from such discrimination. The law prevents discrimination from health insurers and employers. This law does not cover life insurance, disability insurance and longterm care insurance. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.

You will not benefit from taking part. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

You will not benefit from taking part. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

There are no costs to you or your insurance. You will not be paid for taking part. If any of the research leads to new tests, drugs, or other commercial products, you will not share in any profits.

There are no costs to you or your insurance. You will not be paid for taking part. If any of the  
 research leads to new tests, drugs, or other commercial products, you will not share in any profits.

Sometimes, health records have been used against patients and their families. For example, insurance companies may deny a patient insurance or employers may not hire someone with a certain illness (such as AIDS or cancer). The results of genetic research may not apply only to you, but to your family members too. For disease caused by gene changes, the information in one person's health record could be used against family members.

Sometimes, health records have been used against patients and their families. For example, insurance companies may deny a patient insurance or employers may not hire someone with a certain illness (such as AIDS or cancer). The results of genetic research may not apply only to you, but to your family members too. For disease caused by gene changes, the information in one person's health record could be used against family members.
Clinical trial: NCT02154490
Section: Procedures
Subsections: Informed Consent Model For S1400 - **Screening Step**|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Is Involved?|What Is Involved?|Informed Consent Model For S1400 - **Pre-Screening Step**|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Is Involved?|What Is Involved?

(This is to be used for patients who are being screened after progression on previous treatment)
*NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:
This model informed consent form has been reviewed by the DCTD/NCI and is the official consent document for this study. Local IRB changes to this document are allowed. (Institutions should attempt to use sections of this document that are in bold type in their entirety.) Editorial changes to these sections may be made as long as they do not change information or intent. If the institutional IRB insists on making additions, deletions or more substantive modifications to the risks or alternatives sections, they may be justified in writing by the investigator and approved by the IRB. Under these circumstances, the revised language, justification and a copy of the IRB minutes must be forwarded to the SWOG Operations Office for approval before a patient may be *registered to this study.* Please particularly note that the questions related to banking of specimens for future study are in bolded type and may not be changed in any way without prior approval from the SWOG

Before you begin the study, a small piece of tumor sample, which was already removed by surgery or biopsy, will be sent to special laboratories for the study. This tumor sample is required in order for you to take part in this study because the research on the sample is an important part of the study. The result of this testing will determine which sub-study you will be offered. If there is not enough tissue left from a previous surgery or biopsy, you are required to have a biopsy to get more tissue before you can be screened for this study. A separate consent form will be needed for this biopsy. This will be a standard surgical consent form from the institution where the biopsy procedure takes place. If any tumor is left over, it will be stored in the Biobank and used for the laboratory studies  
 within any sub-studies you may be enrolled in. The samples will be kept until there are no additional sub-studies for you to enroll in or they are used up, whichever happens first. The laboratory studies will be discussed in the sub-study consent form. If any tumor is left over after the laboratory studies and there are no additional sub-studies for you to enroll in, and if you agree, it will be stored for biobanking. This will be discussed in the section on optional studies below. Your privacy is very important and the researchers will make every effort to protect it. Your test results will be identified by a unique code and the list that links the code to your name will be kept separate from your sample and health information. Results of the screening test (including which study treatment you are eligible for) will be reported to your study doctor as soon as they are available. The results will be reported to your study doctor even if you are not enrolled into a sub-study. Your doctor will discuss these results with you. Neither you nor your health care plan/insurance carrier will be billed for the collection or testing of the tumor tissue that will be used for this study.

Before you begin the study, a small piece of tumor sample, which was already removed by surgery or biopsy, will be sent to special laboratories for the study. This tumor sample is required in order for you to take part in this study because the research on the sample is an important part of the study. The result of this testing will determine which sub-study you will be offered. If there is not enough tissue left from a previous surgery or biopsy, you are required to have a biopsy to get more tissue before you can be screened for this study. A separate consent form will be needed for this biopsy. This will be a standard surgical consent form from the institution where the biopsy procedure takes place. If any tumor is left over, it will be stored in the Biobank and used for the laboratory studies  
 within any sub-studies you may be enrolled in. The samples will be kept until there are no additional sub-studies for you to enroll in or they are used up, whichever happens first. The laboratory studies will be discussed in the sub-study consent form. If any tumor is left over after the laboratory studies and there are no additional sub-studies for you to enroll in, and if you agree, it will be stored for biobanking. This will be discussed in the section on optional studies below. Your privacy is very important and the researchers will make every effort to protect it. Your test results will be identified by a unique code and the list that links the code to your name will be kept separate from your sample and health information. Results of the pre-screening test (including which study treatment you are eligible for) will be reported to your study doctor once your tumor begins to grow. The results will be reported to your study doctor even if you are not enrolled into a sub-study. Your doctor will discuss these results with you. Neither you nor your health care plan/insurance carrier will be billed for the collection or testing of the tumor tissue that will be used for this study.

If you agree to take part, here is what will happen next:
1) If there is tissue left over after the laboratory studies and there are no additional sub-studies for you to enroll in, your tissue and some related information may be stored in the Biobank, along with samples and information from other people who take part. The samples will be kept until they are used up.  
2) About 1 tablespoon of blood will be collected from a vein in your arm within 42 days of being assigned to a sub-study (at the same time as other study blood tests).  
3) Qualified researchers can submit a request to use the materials stored in the Biobanks. A science committee at the clinical trials organization, and/or the National Cancer Institute, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
4) Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.  
5) Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.

If you agree to take part, here is what will happen next:
1) If there is tissue left over after the laboratory studies and there are no additional sub-studies for you to enroll in, your tissue and some related information may be stored in the Biobank, along with samples and information from other people who take part. The samples will be kept until they are used up.  
2) About 1 tablespoon of blood will be collected from a vein in your arm within 42 days of being assigned to a sub-study.  
3) Qualified researchers can submit a request to use the materials stored in the Biobanks. A science committee at the clinical trials organization, and/or the National Cancer Institute, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
4) Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.  
5) Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.

(This is to be used for patients who are being pre-screened prior to progression on current treatment)
*NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:
This model informed consent form has been reviewed by the DCTD/NCI and is the official consent document for this study. Local IRB changes to this document are allowed. (Institutions should attempt to use sections of this document that are in bold type in their entirety.) Editorial changes to these sections may be made as long as they do not change information or intent. If the institutional IRB insists on making additions, deletions, or more substantive modifications to the risks or alternatives sections, they may be justified in writing by the investigator and approved by the IRB. Under these circumstances, the revised language, justification and a copy of the IRB minutes must be forwarded to the SWOG Operations Office for approval before a patient may be registered to this study. Please particularly note that the questions related to banking of specimens for future study are in bolded type and may not be changed in any way without prior approval from the SWOG

Before you begin the study, a small piece of tumor sample, which was already removed by surgery or biopsy, will be sent to special laboratories for the study. This tumor sample is required in order for you to take part in this study because the research on the sample is an important part of the study. The result of this testing will determine which sub-study you will be offered. If there is not enough tissue left from a previous surgery or biopsy, you are required to have a biopsy to get more tissue before you can be screened for this study. A separate consent form will be needed for this biopsy. This will be a standard surgical consent form from the institution where the biopsy procedure takes place. If any tumor is left over, it will be stored in the Biobank and used for the laboratory studies  
 within any sub-studies you may be enrolled in. The samples will be kept until there are no additional sub-studies for you to enroll in or they are used up, whichever happens first. The laboratory studies will be discussed in the sub-study consent form. If any tumor is left over after the laboratory studies and there are no additional sub-studies for you to enroll in, and if you agree, it will be stored for biobanking. This will be discussed in the section on optional studies below. Your privacy is very important and the researchers will make every effort to protect it. Your test results will be identified by a unique code and the list that links the code to your name will be kept separate from your sample and health information. Results of the screening test (including which study treatment you are eligible for) will be reported to your study doctor as soon as they are available. The results will be reported to your study doctor even if you are not enrolled into a sub-study. Your doctor will discuss these results with you. Neither you nor your health care plan/insurance carrier will be billed for the collection or testing of the tumor tissue that will be used for this study.

Before you begin the study, a small piece of tumor sample, which was already removed by surgery or biopsy, will be sent to special laboratories for the study. This tumor sample is required in order for you to take part in this study because the research on the sample is an important part of the study. The result of this testing will determine which sub-study you will be offered. If there is not enough tissue left from a previous surgery or biopsy, you are required to have a biopsy to get more tissue before you can be screened for this study. A separate consent form will be needed for this biopsy. This will be a standard surgical consent form from the institution where the biopsy procedure takes place. If any tumor is left over, it will be stored in the Biobank and used for the laboratory studies  
 within any sub-studies you may be enrolled in. The samples will be kept until there are no additional sub-studies for you to enroll in or they are used up, whichever happens first. The laboratory studies will be discussed in the sub-study consent form. If any tumor is left over after the laboratory studies and there are no additional sub-studies for you to enroll in, and if you agree, it will be stored for biobanking. This will be discussed in the section on optional studies below. Your privacy is very important and the researchers will make every effort to protect it. Your test results will be identified by a unique code and the list that links the code to your name will be kept separate from your sample and health information. Results of the pre-screening test (including which study treatment you are eligible for) will be reported to your study doctor once your tumor begins to grow. The results will be reported to your study doctor even if you are not enrolled into a sub-study. Your doctor will discuss these results with you. Neither you nor your health care plan/insurance carrier will be billed for the collection or testing of the tumor tissue that will be used for this study.

If you agree to take part, here is what will happen next:
1) If there is tissue left over after the laboratory studies and there are no additional sub-studies for you to enroll in, your tissue and some related information may be stored in the Biobank, along with samples and information from other people who take part. The samples will be kept until they are used up.  
2) About 1 tablespoon of blood will be collected from a vein in your arm within 42 days of being assigned to a sub-study (at the same time as other study blood tests).  
3) Qualified researchers can submit a request to use the materials stored in the Biobanks. A science committee at the clinical trials organization, and/or the National Cancer Institute, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
4) Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.  
5) Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.

If you agree to take part, here is what will happen next:
1) If there is tissue left over after the laboratory studies and there are no additional sub-studies for you to enroll in, your tissue and some related information may be stored in the Biobank, along with samples and information from other people who take part. The samples will be kept until they are used up.  
2) About 1 tablespoon of blood will be collected from a vein in your arm within 42 days of being assigned to a sub-study.  
3) Qualified researchers can submit a request to use the materials stored in the Biobanks. A science committee at the clinical trials organization, and/or the National Cancer Institute, will review each request. There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
4) Neither you nor your study doctor will be notified when research will be conducted or given reports or other information about any research that is done using your samples.  
5) Some of your genetic and health information may be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.
Clinical trial: NCT02154490
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Is This Study Being Done?|Why Do People Do Research With Specimens?|Why Do People Do Research With Specimens?|Why Is This Study Being Done?|Why Is This Study Being Done?|Why Do People Do Research With Specimens?|Why Do People Do Research With Specimens?

The purpose of this study screening step is to test specific genes and proteins in your tumor sample. Based on the test results, you will be assigned to one of the treatment studies. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor. You may choose to not take part in the treatment study assigned to you. Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in treatment on this research study. We expect that between 500 and 800 patients will be screened for this study each year. We also  
 expect that about 300 to 500 patients per year will go on to receive treatment on one of the assigned treatment studies.

The purpose of pre-screening is to obtain a sample of your tumor while you are on your current  
 cancer treatment. If you agree to the prescreening, your tumor sample will be tested by a lab for specific genes and proteins. You will continue with your current treatment as long as it is continuing to help you. However, if your tumor begins to grow, prescreening will make it easier for you to take part in one of the treatment studies matching your tumor to an appropriate study drug. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor. Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in this research study. You may choose not to take part in the treatment study assigned to you. We expect that between 500 and 800 patients will be screened for this study each year. We also expect that about 300 to 500 patients per year will go on to receive treatment on one of the assigned treatment studies.

Research with specimens can help to find out more about what causes cancer, how to prevent it, how to treat it, and how to cure it. Research using specimens can also answer other health questions. Some of these include finding the causes of diabetes and heart disease, or finding genetic links to Alzheimer's.

Research with specimens can help to find out more about what causes cancer, how to prevent it, how to treat it, and how to cure it. Research using specimens can also answer other health questions. Some of these include finding the causes of diabetes and heart disease, or finding genetic links to Alzheimer's.

The purpose of this study screening step is to test specific genes and proteins in your tumor sample. Based on the test results, you will be assigned to one of the treatment studies. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor. You may choose to not take part in the treatment study assigned to you. Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in treatment on this research study. We expect that between 500 and 800 patients will be screened for this study each year. We also  
 expect that about 300 to 500 patients per year will go on to receive treatment on one of the assigned treatment studies.

The purpose of pre-screening is to obtain a sample of your tumor while you are on your current  
 cancer treatment. If you agree to the prescreening, your tumor sample will be tested by a lab for specific genes and proteins. You will continue with your current treatment as long as it is continuing to help you. However, if your tumor begins to grow, prescreening will make it easier for you to take part in one of the treatment studies matching your tumor to an appropriate study drug. We do not know how accurate this screening will be in matching your tumor type to a drug to treat your tumor. Before you decide to get treatment on the study, you will be given information about the treatment and you will be asked if you wish to take part in this research study. You may choose not to take part in the treatment study assigned to you. We expect that between 500 and 800 patients will be screened for this study each year. We also expect that about 300 to 500 patients per year will go on to receive treatment on one of the assigned treatment studies.

Research with specimens can help to find out more about what causes cancer, how to prevent it, how to treat it, and how to cure it. Research using specimens can also answer other health questions. Some of these include finding the causes of diabetes and heart disease, or finding genetic links to Alzheimer's.

Research with specimens can help to find out more about what causes cancer, how to prevent it, how to treat it, and how to cure it. Research using specimens can also answer other health questions. Some of these include finding the causes of diabetes and heart disease, or finding genetic links to Alzheimer's.
Clinical trial: NCT02154490
Section: Voluntary Participation
Subsections: My Signature Agreeing To Take Part In The Screening Step Of This Study|My Signature Agreeing To Take Part In The Screening Step Of This Study|My Signature Agreeing To Take Part In The Screening Step Of This Study|My Signature Agreeing To Take Part In The Screening Step Of This Study

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature Date of signature_____________________________________

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature Date of signature_____________________________________

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature Date of signature_____________________________________

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'. Participant's signature Date of signature_____________________________________
Clinical trial: NCT02154490
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|What If I Change My Mind?|What If I Change My Mind?|Can I Stop Taking Part In This Study?|Can I Stop Taking Part In This Study?|What If I Change My Mind?|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
- If your health changes and the study is no longer in your best interest - If new information becomes available
- If you do not follow the study rules
- If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
- If your health changes and the study is no longer in your best interest - If new information becomes available - If you do not follow the study rules
- If the study is stopped by the sponsor, IRB or FDA.

If you decide you no longer want your samples to be used, you can call the study doctor, _________________, *(insert name of study doctor for main trial)* at ________________________ *(insert telephone number of study doctor for main trial)* who will Screening Consent Page 12 Version Date 12/18/20 let the researchers know. Then, any sample that remains in the bank will no longer be used. Samples or related information that have already been given to or used by researchers will not be returned.

If you decide you no longer want your samples to be used, you can call the study doctor,
_________________, *(insert name of study doctor for main trial)* at ________________________ *(insert telephone number of study doctor for main trial)* who will let the researchers know. Then, any sample that remains in the bank will no longer be used. Samples or related information that have already been given to or used by researchers will not be returned.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
- If your health changes and the study is no longer in your best interest - If new information becomes available
- If you do not follow the study rules
- If the study is stopped by the sponsor, IRB or FDA.

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you out of the study:
- If your health changes and the study is no longer in your best interest - If new information becomes available - If you do not follow the study rules
- If the study is stopped by the sponsor, IRB or FDA.

If you decide you no longer want your samples to be used, you can call the study doctor, _________________, *(insert name of study doctor for main trial)* at ________________________ *(insert telephone number of study doctor for main trial)* who will Screening Consent Page 12 Version Date 12/18/20 let the researchers know. Then, any sample that remains in the bank will no longer be used. Samples or related information that have already been given to or used by researchers will not be returned.

If you decide you no longer want your samples to be used, you can call the study doctor,
_________________, *(insert name of study doctor for main trial)* at ________________________ *(insert telephone number of study doctor for main trial)* who will let the researchers know. Then, any sample that remains in the bank will no longer be used. Samples or related information that have already been given to or used by researchers will not be returned.