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Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer

This study is currently recruiting participants.
Verified October 16, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109420
First Posted: April 23, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
April 22, 2010
April 23, 2010
October 19, 2017
May 1, 2010
Not Provided
To evaluate the natural history of FNMTC [ Time Frame: 20 years ]
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Complete list of historical versions of study NCT01109420 on ClinicalTrials.gov Archive Site
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Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer

Background:

- Researchers are studying types of thyroid cancer that seem to cluster in families. Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer, but little is known about possible genes that may cause the cancer. More research is needed to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that it can be diagnosed and treated at an early stage.

Objectives:

  • To evaluate the natural history of FNMTC.
  • To determine the best screening strategy for FNMTC.
  • To identify genes that may indicate susceptibility to FNMTC.

Eligibility:

- Individuals at least 7 years of age who have two first-degree relatives (e.g., parents, children, siblings) who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer.

Design:

  • Participants will be evaluated by family history pedigree, physical examination, imaging (including possible neck ultrasound and radioactive iodine scans), and laboratory testing.
  • Participants who agree to have blood or other biological samples collected will be asked to enroll in an additional study to provide the appropriate samples and tissues.
  • After the initial study evaluation, participants who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies. Participants who are found to have a malignant thyroid tumor will be informed of possible treatment options.

Background:

  • Thyroid cancer is one of the fastest growing cancer diagnoses in the United States.
  • Non-medullary thyroid cancer accounts for 95% of all thyroid cancer cases.
  • Up to 8% of all non-medullary thyroid cancers are hereditary.
  • Familial non-medullary thyroid cancer (FNMTC) is more aggressive than sporadic disease.
  • No susceptibility gene for FNMTC has been identified.
  • The best approach for screening at risk family members for FNMTC is unknown.
  • This protocol is designed to determine the natural history and best screening strategy for FNMTC, and to identify susceptibility gene(s) for FNMTC.

Objectives:

  • To evaluate the natural history of FNMTC.
  • To determine the best screening strategy for FNMTC.
  • To identify susceptibility gene(s) for FNMTC.

Eligibility:

- An individual with 2 first-degree relatives who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)

Or

Any member of an affected family.

  • Age greater than 7 years
  • Adults must be able to understand and sign the informed consent document
  • Adults must be able to complete the family history questionnaire

Design:

  • Prospective observational study.
  • Demographic, clinical and pathologic data will be collected from the medical record and patient interview for each patient participant and family members. Data will be securely stored in a computerized database. When possible, pathology slides and blocks will be obtained from all cases in the family for verification of diagnoses.
  • Patients will be evaluated by family history pedigree, physical examination, imaging, and laboratory testing as indicated.
  • Participants who agree to have biospecimens collected will be co-enrolled on the endocrine tissue procurement protocol 09-C-0242. These would include peripheral blood or buccal cell samples and thyroid tissue if the participants have surgery.
  • After their initial on-study evaluation, patients who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies.
  • Treatment of patients with a thyroid neoplasm will be performed based on established clinical guidelines.
  • Projected accrual will be 20 patients per year for a total of 15 years. Thus, we anticipate accruing 300 patients on this protocol.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Medullary Thyroid Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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  • INCLUSION CRITERIA:

    1. An individual with 2 first-degree relatives who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer. (Note: as this is a familial study, subjects do not need to present with the disease.)

      OR

      Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)

    2. Age greater than 7 years.

      Note: at least one parent must provide consent for pediatric patients; patients will be re-consented once they reach 18 years of age.

    3. Adults must be able to understand and sign the informed consent document.
    4. Adults must be able to complete the family history questionnaire.
Sexes Eligible for Study: All
7 Years to 100 Years   (Child, Adult, Senior)
Yes
Contact: Roxanne E Merkel (301) 402-4395 ncieobinquiry@mail.nih.gov
Contact: Electron Kebebew, M.D. (240) 760-6153 kebebewe@mail.nih.gov
United States
 
 
NCT01109420
100102
10-C-0102
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
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Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
October 16, 2017