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Trial record 1 of 1 for:    10-dk-0102
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Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01109420
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date April 22, 2010
First Posted Date April 23, 2010
Last Update Posted Date January 27, 2023
Actual Study Start Date August 12, 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 29, 2022)
To evaluate the natural history of FNMTC [ Time Frame: end of study ]
Evaluation the natural history of FNMTC
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Official Title Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer
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.
Detailed 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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.)
Condition Non-Medullary Thyroid Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 1/ Cohort 1
    Affected with non-medullary thyroid cancer
  • 2/ Cohort 2
    Non-affected members of families with non-medullary thyroid cancer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 29, 2022)
500
Original Estimated Enrollment
 (submitted: April 22, 2010)
300
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Padmasree Veeraraghavan, N.P. (301) 451-7710 ncieobinquiry@mail.nih.gov
Contact: Joanna Klubo-Gwiezdzinska, M.D. (301) 496-5052 joanna.klubo-gwiezdzinska@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01109420
Other Study ID Numbers 100102
10-DK-0102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: .Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Original Responsible Party Not Provided
Current Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Original Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Joanna Klubo-Gwiezdzinska, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 25, 2023