Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01109420
First received: April 22, 2010
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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.

Condition
Non-Medullary Thyroid Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: April 2010
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 the age of majority.

    3. Adults must be able to understand and sign the informed consent document.
    4. Adults must be able to complete the family history questionnaire.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109420

Contacts
Contact: Candice M Cottle-Delisle, R.N. (301) 402-4395 cottlec@mail.nih.gov
Contact: Electron Kebebew, M.D. (301) 496-5049 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kaitlyn Chambers    301-402-4395    kaitlyn.chambers@nih.gov   
Contact: Roxanne Merkel    (301) 402-4395    merkelre@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01109420     History of Changes
Other Study ID Numbers: 100102, 10-C-0102
Study First Received: April 22, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Thyroid Malignancy
Hereditary Thyroid Cancer
Inherited Thyroid Cancer
Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014