Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 21 October 2022

Summary

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.

Description

Study Description:

This is a prospective cohort study of individuals with or at risk for non-medullary thyroid cancer. Individuals will be studied over time within the context of their families in order to quantify prospective risks of cancers in family members, to establish the natural history of FNMTC, define the spectrum of diseases within the families, to identify precursor states, to try to assess the contribution of genetic and environmental components of risk, and to develop effective screening strategies.

Objectives
  1. To evaluate the natural history of familial non-medullary thyroid cancer (FNMTC).
  2. To determine the best screening strategy for FNMTC.
  3. To identify susceptibility gene(s) for FNMTC.
Endpoints

Not applicable

Details
Condition Non-Medullary Thyroid Cancer
Clinical Study IdentifierNCT01109420
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects will be selected for this protocol based on either a clinical diagnosis of
OR
non-medullary thyroid cancer and the presence of one family member with the disease or the
presence of 2 living family members with this disease. Patient selection for this protocol
will not be based on gender, race, or ethnic background
In order to be eligible to participate in this study, an individual must meet all of the
following criteria
Adults or minor (>= 7 years+), males and females
An unaffected individual with (Bullet) 2 first-degree relatives who have or have had
nonmedullary thyroid cancer
Adults must be able to complete the family history questionnaire
An affected individual with documented diagnosis of non-medullary thyroid cancer and
(Bullet) 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.)
Adults must be able to understand and the willingness to sign the informed consent
document

Exclusion Criteria

An individual who meets any of the following criteria will be not be allowed to enroll in
this study
Subjects unwilling/unable to give informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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