Clinical trial: NCT01306045
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

You can choose not to participate in the study. The choice to participate is completely up to you. No matter what you decide to do, your decision will not affect the medical care or benefits to which you are otherwise entitled.
Clinical trial: NCT01306045
Section: Confidentiality
Subsections: Confidentiality And Availability Of Genetic Data|Confidentiality Protections Provided In This Study|Certificate Of Confidentiality|Privacy Act

The exact order of the base pairs (chemical letters) in your DNA is known as your DNA sequence. We will be looking at sections of your DNA sequence (in the EGFR gene) and not your entire sequence. Your DNA sequence that is determined as part of the genetic testing will be labeled with a number and not your name. Only medical personnel involved in this study will have access to both your name and DNA sequence. You need to be aware that DNA sequence is like a fingerprint. Theoretically, if enough DNA sequence information is available, someone could identify you based on your DNA sequence if they know some of your DNA sequence already.

Will your medical information be kept private?  
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We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
1. The NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
2. National Institutes of Health Intramural Institutional Review Board
When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens and data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:  
is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
is for other research; is disclosed with your consent
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.  
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The Federal Privacy Act generally protects the confidentiality of your NIH medical information that we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT01306045
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study? Physical Risks|Emotional And Psychological Risks|Psychological Or Social Risks Associated With Loss Of Privacy|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

Risks associated with the blood draw include pain at the needle site, bruising, possible dizziness if you stand up quickly and possible inflammation of the vein or infection at the needle site. Care will be taken to avoid these complications.

Genetic information about you and your family may be discovered during this genetic testing. Many aspects of life can be affected by knowing this information. An important thing to consider in deciding whether or not to participate in this type of research is the effect that knowing information about your genetic risks could have on you and others. Not all family members may feel the same about involvement in this research project. Some family members may not wish to participate in the study. Your emotional well being could be affected by information about how your genetic risks could change your health. You might become anxious, depressed or stressed by learning this information. In addition, because this information could have implications for the risks and future health of your children, brothers and sisters and other relatives, it could also affect your relationships with them. Part of the research may involve testing genetic material from parents and their children. We may learn that a child was adopted or that a child's stated father is not the natural father. Our policy is to not reveal this information unless it has direct medical or reproductive implications for you or your family.

Your privacy is very important to us and we will use many safety measures to protect your privacy. However, in spite of all of the safety measures that we will use, we cannot guarantee that your identity will never become known. Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, and other blood relatives. Consequently, it may be possible that genetic information from them could be used to help identify you. Similarly, it may be possible that genetic information from you could be used to help identify them.  
While neither the public nor the controlled-access databases developed for this project will contain information that is traditionally used to identify you, such as your name, address, telephone number, or social security number, people may develop ways in the future that would allow someone to link your genetic or medical information in our databases back to you. For example, someone could compare information in our databases with information from you (or a blood relative) in another database and be able to identify you (or your blood relative). It also is possible that there could be violations to the security of the computer systems used to store the codes linking your genetic and medical information to you.  
Since some genetic variations can help to predict the future health problems of you and your relatives, this information might be of interest to health providers, life insurance companies, and others. Patterns of genetic variation also can be used by law enforcement agencies to identify a person or his/her blood relatives. Therefore, your genetic information potentially could be used in ways that could cause you or your family distress.  
There also may be other privacy risks that we have not foreseen.  
There are state and federal laws that protect against genetic discrimination. There is also a federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not apply to members of the United States military, to veterans obtaining health care through the Veteran's Administration or the Indian Health Service. Lastly, GINA does not forbid insurance medical underwriting based on your current health status. The research team may share your information with:
The Department of Health and Human Services (HHS), to complete federal responsibilities for audit or evaluation of this project; Public health agencies, to complete public health reporting requirements; NIH representatives, to complete NIH responsibilities for oversight of this study; Your primary care physician if a medical condition that needs urgent attention is discovered; Appropriate authorities to the extent necessary to prevent serious harm to yourself or others.

This research may increase our understanding of genetic risk factors for lung cancer. There may be no direct benefit to you or your family from participating in this research. However, information learned from this study may help your doctor manage your care. We hope that this and related research may contribute to the early diagnosis of lung cancer in the future. Treatment might be more effective when tumors are found early.
Clinical trial: NCT01306045
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You Take Part In This Research Study?

Before the testing If you choose to participate in the study, you will need to have the following before the genetic testing:  
Clinic visit, which will include a medical and family history and a physical examination. Speak with a genetics health care professional (in person or by phone before the genetic testing is done), who will explain the testing, the types of information that may be learned, the limitations of the testing, and any potential healthcare recommendations that could result. You will be able to ask any questions that you have about the genetic testing.
If you are a smoker, you will be offered help to stop smoking as part of this study.
Clinical trial: NCT01306045
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

Your blood and tissue samples contain genes, which are made up of DNA (deoxyribonucleic acid) which serves as the "instruction book" for the cells that make up our bodies. We are conducting a study to see if it is possible to analyze the genes of patients with lung cancer and cancers of the thymus and based on such analysis provide personalized treatment with drugs that target the specific gene abnormalities (mutations) found in the tumor.  
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As part of this study, we are also studying specific hereditary mutations (those mutations which can be passed from one generation to the next) and their possible role in the risk of developing lung cancer. Genetic testing for hereditary mutations is part of the care of individuals who have a family history of other types of cancers, such as breast, ovarian, or colon cancer. However, little is known about hereditary mutations that may be a factor in the development of lung cancer.  
We are specifically interested in the epidermal growth factor receptor (EGFR) gene. Nonhereditary mutations (those mutations found in the tumor and not passed from one generation to another) in this gene are known to be present in the tumor of some individuals with lung cancer and may have implications in selection of treatment in such patients. Hereditary mutations of EGFR gene have been reported very rarely in the medical literature thus far. From the limited available knowledge on hereditary mutations of EGFR gene, we do not know if having this mutation confers an increased risk of developing lung cancer. Because one of your first-degree relatives (your parents, siblings, or children) carries a mutation in the EGFR gene, we are requesting your permission to test your blood for the same mutation. By studying the pattern of these mutations in patients with lung cancer and their family members, we hope to gain a better understanding of the role of hereditary EGFR gene mutations in the development of lung cancer. If testing reveals a hereditary mutation in your EGFR gene, we would also like to invite your adult first-degree relatives (your parents, siblings, and children) to participate in the study and undergo genetic testing.

You are being asked to participate in the study because you are at least 18 years old and one of your first-degree relatives (parents, siblings, or children) has a hereditary mutation of the EGFR gene.
Clinical trial: NCT01306045
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.
Clinical trial: NCT01306045
Section: Withdrawal from Study
Subsections: Stopping Participation

You can stop taking part in the study at any time. Tell your study doctor if you would like to stop. Your participation could end early if the study is closed for any reason