Clinical trial: NCT02408887
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Instead of being in this study, you have these options:
- Getting treatment or care for your cancer without being in a study  
- Taking part in another study
- Getting 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. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT02408887
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

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:  
- The National Cancer Institute (NCI) and other government agencies which are involved in keeping research safe for people.  
- National Institutes of Health Intramural Institutional Review Board  
PATIENT IDENTIFICATION CONTINUATIONSHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 9 of 12 pages A description of this clinical trial will be available on http://www.Clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most the Web site will include a summary of the results. You can search this Web site at any time.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
- will be used for auditing or program evaluation internally by the NIH; or
- must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure; - is for other research.
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT02408887
Section: Duration of Study Involvement
Subsections: During The Study|1 Day After Surgery|2 Weeks After Surgery|3 Months After Surgery|6 Months After Surgery|1 Year After Surgery

This study is a randomized study. You will be placed into one of two groups by chance (like flipping a coin). One group will undergo surgery to remove the thyroid gland only. During the surgery, if the investigator discovers that your cancer has spread to the lymph nodes in your neck, they will also be removed. If no evidence of cancer is found in your lymph nodes they will not be removed. The second group will undergo surgery to remove the thyroid as well as the lymph nodes in your neck. You will not be told during the trial which group you have been assigned to. This is called a blind. However, the blind may be broken if information is critical for your medical care. For example if you are assigned to group 1 and cancer is discovered in your lymph nodes, this will be discussed with you and you will be told if the lymph nodes in your neck have been removed.  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 3 of 12 pages

- Fill out 4 questionnaires so that we can find out about your quality of life, neck pain, if you are having problems with your voice or if you are having trouble swallowing before your surgery.  
- Undergo a flexible laryngoscopy to look at your vocal cords - Have some blood drawn for routine laboratory tests

- Fill out 4 questionnairesso that we can find out about your quality of life, neck pain, if you are having problems with your voice or if you are having trouble swallowing before your surgery.  
PATIENT IDENTIFICATION CONTINUATIONSHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 4 of 12 pages  
- Have some blood drawn for routine laboratory tests - If the study doctor believes it is necessary, you will undergo a flexible laryngoscopy to look at your vocal cords. Most patients do not require this.

- Fill out one questionnaire so that we can find out about your quality of life - Have some blood drawn for routine laboratory tests - Ultrasound of your thyroid and soft tissue in the neck - All patients will need to either stop thyroid hormone treatment for 2 weeks or, if the study doctor believes that it's in your best interest, you will be offered recombinant thyroid hormone as part of standard of care in a preparation for a specific blood test. You will have the opportunity to discuss with doctors regarding these options.  
- If necessary, as part of your standard care, you will be offered the opportunity to be treated with I131, which is a radioactive form of iodine. I131 could destroy any remaining thyroid cancer cells or thyroid tissue present in your body. This is called remnant ablation. The study doctor will discuss with you whether this is in your best interest and you will be given the opportunity to decide on your treatment.  
- If the study doctor believes it is necessary, a diagnostic whole body radioiodine scan
(WBS) will be performed
To prepare for a WBS, you will be asked to swallow a capsule or liquid that contains a very small amount of radioactive iodine (RAI). This will be absorbed by any remaining thyroid cells in your body. You will then be asked to return for the scan in about 48 hours. This involves lying down under a large camera that scans for x-rays being emitted by any remaining radioactive iodine that may have been captured in your body. If any thyroid or thyroid cancer cells are present, they may show up as spots on the x-ray film.

- Fill out 4 questionnaires so that we can find out about your quality of life, neck pain, if you are having problems with your voice or if you are having trouble swallowing before your surgery.  
- If a laryngoscopy showed that your vocal cords were not working well on day 1, you will undergo a flexible laryngoscopy to look at your vocal cords.  
- Have some blood drawn for routine laboratory tests  
PATIENT IDENTIFICATION CONTINUATIONSHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 5 of 12 pages  
- Ultrasound of your thyroid and soft tissue in the neck

If you underwent remnant ablation you will be given TSH for 2 consecutive days or if you have been taking thyroid hormone, undergo thyroid hormone withdrawal and then after 4 weeks have some blood drawn for routine tests. If you did not undergo remnant ablation, you will receive TSH for 2 consecutive days and then have blood drawn for routine tests.  
All study subjects will also be required to:  
- Fill out one questionnaire so that we can find out about your quality of life - Undergo a diagnostic whole body radioiodine scan (WBS)
- Have an ultrasound of your thyroid and soft tissue in the neck
If your bloodwork shows elevated serum thyroglobulin, this could be an indication that your cancer has metastasized (spread to other parts of your body) and we will need to perform additional standard tests to confirm or rule out the presence of metastatic disease. We will continue to follow you to see if your cancer returns once each year f or 10 years after surgery. You will have a detailed physical exam, blood drawn for routine laboratory tests and an ultrasound of the soft tissues in your neck or other imaging that the study doctor feels is in your best interest. At year 5 and year 10 after surgery, we will ask you to complete a questionnaire so that we may get some information about your quality of life.
Clinical trial: NCT02408887
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT02408887
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?**|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

If you choose to take part in this study, there is a risk that:  
- 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

The aim of this study is to see if removal of the lymph nodes in addition to the thyroid gland will result in less recurrence (tumor coming back) compared to removal of the thyroid gland alone. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits may include a lower rate of radioiodine use, a lower rate of recurrence, and improved quality of life. Because it is not proven that removal of the lymph nodes will have any additional benefit, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have papillary thyroid cancer.
Clinical trial: NCT02408887
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You **Take Part In This Research Study?** Before You Begin The Study|Questionnaires|Pregnancy Test|Flexible Laryngoscopy|Flexible Laryngoscopy|Surgery|Surgery|Standard Of Care Treatment|Birth Control|Blood Draw|Surgery|Surgery|Ultrasound Guided Biopsy|Flexible Laryngoscopy|Flexible Laryngoscopy|Whole Body Radiodine Scan|Neck Ultrasound

All research studies have specific criteria for entry to allow for valid interpretation of the study results and safety of participants, known as eligibility criteria. Before you begin this study you will need to have the following exams and tests to make sure you are eligible for this study. The exams and tests are part of regular cancer care and may be done even if you do not join the study. If you recently had some of the tests, they may not need to be repeated.  
- History and physical examination, including vital signs (height, weight, blood pressure, heart rate, temperature, breathing rate)
- Standard blood tests to measure including a complete blood count, chemistry panel, tests to check the levels of certain hormones in your body e.g. thyroid stimulating hormone (TSH)
- Tumor biopsy (if not previously done) - Ultrasound and/or CT scan of your thyroid and neck
If you meet the eligibility criteria for this study you will be offered the option of participating.

Before you undergo surgery, you will be asked to fill out 4 questionnaires so that we can find out about your quality of life, neck pain, if you are having problems with your voice or if you are having trouble swallowing before your surgery. This should take about 15 to 20 minutes. Additionally, you will undergo a flexible laryngoscopy (described below) so that we can look at how well your vocal cords work.

A pregnancy test will also be performed if you are a woman that can have children. If the test is positive, your surgery will be postponed.

In flexible laryngoscopy, a thin, flexible viewing tube (called a laryngoscope) is passed through the nose and guided to the vocal cords. You will be asked to sit upright in an exam chair. A local anesthetic will be sprayed into the back of your nose and throat to numb these areas and suppress the gag reflex (however, you may still gag and feel some discomfort when the laryngoscope is first inserted). The study doctor will then insert the scope through one nostril and closely inspect your vocal cords. Photographs may be taken with a tiny camera attached to the scope. This procedure usually takes 5 to 10 minutes.

In some cases, local anesthesia medications (spray) can cause complications, such as irregular heartbeats and breathing problems. These complications are not common. Allergic reactions are also possible but not common. If they do occur, they typically develop within a few minutes after the anesthesia is given. The study doctors can provide immediate medical attention if that happens.  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 7 of 12 pages

Within 4 weeks after completing these tests, you will undergo surgery. You will then be required to complete a few tests at 1 day, 2 weeks, 3 months, 6 months and 1 year after surgery. Some of these procedures are part of routine care for people with papillary thyroid cancer (people with this disease may have these procedures whether they are in a clinical trial or not). A brief description of what will be done at each time point is indicated below:

The side effects from the surgery are the same as you would have if you received standard surgery for papillary thyroid cancer anyplace. You will have the risks of the surgery explained to you prior to the surgery and you will sign a separate consent for that procedure.

Treatments covered under this study may include a single medication or a combination of medications, surgery or radiation to treat your cancer. These treatments will not be experimental. Your doctors will describe your treatment plan to you in detail before asking you to sign this consent form. You may be asked to sign a separate consent form for any treatment procedures not outlined in this consent.

If you are a woman who can become pregnant, you will need to practice an effective form of birth control before starting study and for 3 months after surgery. If you think that you are pregnant, you should tell your study doctor or nurse at once. Effective forms of birth control include:  
- abstinence
- intrauterine device (IUD)  
PATIENT IDENTIFICATION CONTINUATIONSHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 6 of 12 pages  
- hormonal [birth control pills, injections, or implants]
- tubal ligation
- vasectomy

Side effects of blood draws include pain and bruising in the area where the needle was placed, lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood cell count (anemia) can develop.

Within 4 weeks after completing these tests, you will undergo surgery. You will then be required to complete a few tests at 1 day, 2 weeks, 3 months, 6 months and 1 year after surgery. Some of these procedures are part of routine care for people with papillary thyroid cancer (people with this disease may have these procedures whether they are in a clinical trial or not). A brief description of what will be done at each time point is indicated below:

The side effects from the surgery are the same as you would have if you received standard surgery for papillary thyroid cancer anyplace. You will have the risks of the surgery explained to you prior to the surgery and you will sign a separate consent for that procedure.

A hollow needle is used to collect cell samples from your tumor using an ultrasound for guidance. The needle is put in 3 to 6 times to get the samples, or cores. This procedure usually causes only brief discomfort at the site from which the biopsy is taken and you will be of f ered medication to help numb the pain. Biopsy collection may cause bruising, bleeding, and occasional pain during swallowing but usually does not leave scars. Rarely infection may occur at the needle site. You may experience significant discomfort from where the needle punctures the skin. If this occurs, pain medication will be provided to you.

In flexible laryngoscopy, a thin, flexible viewing tube (called a laryngoscope) is passed through the nose and guided to the vocal cords. You will be asked to sit upright in an exam chair. A local anesthetic will be sprayed into the back of your nose and throat to numb these areas and suppress the gag reflex (however, you may still gag and feel some discomfort when the laryngoscope is first inserted). The study doctor will then insert the scope through one nostril and closely inspect your vocal cords. Photographs may be taken with a tiny camera attached to the scope. This procedure usually takes 5 to 10 minutes.

In some cases, local anesthesia medications (spray) can cause complications, such as irregular heartbeats and breathing problems. These complications are not common. Allergic reactions are also possible but not common. If they do occur, they typically develop within a few minutes after the anesthesia is given. The study doctors can provide immediate medical attention if that happens.  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 7 of 12 pages

For this procedure a small amount of radiotracer is ingested. Nuclear medicine diagnostic procedures have been used for more than five decades, and there are no known long-term adverse effects from such low-dose exposure. In rare circumstances, it is possible to have an allergic reaction to the tracer.

For standard diagnostic ultrasound, there are no known harmful effects on humans. You should talk to your study doctor about any symptoms that you experience while taking part in the study.
Clinical trial: NCT02408887
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

In many cases, papillary thyroid cancer often spreads to the lymph nodes in the neck. Unfortunately, standard imaging techniques sometimes cannot detect if a person's cancer has spread to the lymph nodes. This study will compare whether removing lymph nodes in the neck when they do not yet show evidence of cancer, during thyroid surgery, is better and results in less recurrence of cancer than when only the thyroid is removed.  
PATIENT IDENTIFICATION CONSENT TOPARTICIPATE INACLINICAL RESEARCHSTUDY  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09) P.A.: 09-25-0099  
File in Section 4: Protocol Consent (1)

You are being asked to take part in this trial because you have been diagnosed with papillary thyroid cancer or you have thyroid nodules that are suspicious for papillary thyroid cancer and there is no evidence that your disease has spread to other parts of your body.
Clinical trial: NCT02408887
Section: Withdrawal from Study
Subsections: Stopping Study Participation

In addition to completion of 10 years of follow up, your doctor may decide to remove you f rom this study for the following reasons:
- if he/she believes that it is in your best interest  
- if new information shows that another treatment would be better for you  
PATIENT IDENTIFICATION CONTINUATIONSHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 15-C-0105 CONTINUATION: page 8 of 12 pages In this case, you will be informed of the reason that you are being removed from the study. Participation in this study is voluntary. You may leave the study at any time. You will be given a copy of the consent form for your records. There are no penalties for leaving the study. If you choose not to participate in this study this will not affect your care or your ability to participate in other clinical trials at the NIH. If you decide to stop taking part in the study, we would like you to talk to the study doctor first. If you leave the study, any remaining data of yours that have been obtained for the study can be destroyed at your written request. However, data that have already been distributed to other researchers or placed in the research databases cannot be withdrawn.  
You may ask our staff to answer any and all questions and we invite you to do so. Any new findings that relate to your participation will be discussed with you.