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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02747888
Other study ID # 15-159
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2016
Est. completion date March 1, 2029

Study information

Verified date April 2024
Source Dana-Farber Cancer Institute
Contact Junne Kamihara, MD, PhD
Phone 617.632.3044
Email junne_kamihara@dfci.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in children and families, with a particular interest in understanding genes and other factors that may put individuals at risk for developing thyroid cancer and thyroid nodules. - In this study, family and medical history information is collected alongside a blood or saliva sample for genetic studies. - Individuals with a past or present childhood thyroid cancer/nodule or a thyroid cancer suspected to be inherited in their family are invited to participate.


Description:

The purpose of this research study is to learn more about risk factors for inherited thyroid cancer. The investigators would like to use the participant DNA to look for alterations in genes. The investigator will perform DNA sequencing and other genetic studies to identify errors in the genes that may contribute to the formation of thyroid nodules and cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date March 1, 2029
Est. primary completion date March 1, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Individual pediatric patient with current or previous known or suspected thyroid cancer or nodule(s). - Individual adult patient with current or previous known or suspected thyroid cancer or nodule(s) if they come from a family with a high suspicion of hereditary cancer (as below). - Individuals from families with a high suspicion of hereditary thyroid cancer: - Families with a current or previous diagnosis of a thyroid cancer/nodule occurring in childhood (<18 years old). - Families with a high suspicion of hereditary thyroid cancer/nodules other than above to include: - Families with thyroid cancer in multiple individuals - Families with thyroid cancer and a known genetic syndrome - Families with thyroid cancer and a suspected genetic syndrome (e.g. multiple childhood cancers in the family, multiple primary cancers, multiple endocrinopathies, etc.) Exclusion Criteria: - Individuals who are unable to give informed consent. - Individuals who are unable to complete study materials.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
•Referral to Genetic Counselor, if indicated


Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who have childhood or suspected familial thyroid nodules/cancer 2 years
Primary Number of germline mutations identified associated with thyroid cancer predisposition 2 years
Primary Prevalence of suspected familial thyroid cancer among those with childhood thyroid nodules/cancer 2 years
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