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Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer


N/A
7 Years
N/A
Open (Enrolling)
Both
Non-Medullary Thyroid Cancer

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Trial Information

Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Electron Kebebew, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

100102

NCT ID:

NCT01109420

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Non-Medullary Thyroid Cancer
  • Thyroid Malignancy
  • Hereditary Thyroid Cancer
  • Inherited Thyroid Cancer
  • Thyroid Cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892