Recruiting

Genetic Studies

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT01109420

Conditions

Non-Medullary Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Non-Medullary Thyroid Cancer

Study ID

NCT01109420

Start date

Aug 12, 2010

Status verified date

Aug 18, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

Subjects will be selected for this protocol based on either a clinical diagnosis of 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

OR

-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.
  • Adults must be able to complete the family history questionnaire.

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Affected with non-medullary thyroid cancer

2/ Cohort 2

Non-affected members of families with non-medullary thyroid cancer

Primary outcome measure

  • To evaluate the natural history of FNMTC [ Time Frame: end of study ]

Central Contacts and Locations

Central contacts

Padmasree Veeraraghavan, R.N.

(301) 451-7710ncieobinquiry@mail.nih.gov

Joanna Klubo-Gwiezdzinska, M.D.

(301) 496-5052joanna.klubo-gwiezdzinska@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Sep 8, 2026

Last verified

Aug 18, 2026

Keywords

  • Hereditary Cancer
  • Susceptibility Gene(s) for Thyroid Cancer
  • Screening at Risk Family Members
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-09-08.