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Hereditary Risk Factors for Thyroid Cancer

Primary Purpose

Thyroid Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

•Referral to Genetic Counselor, if indicated

About this trial

This is an interventional screening trial for Thyroid Cancer focused on measuring Thyroid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Lower Suspected Familial Predisposition

Higher Suspected Familial Predisposition

Arm Description

Lower Suspected Familial Predisposition Screening and Enrollment: Consent, Family HX, Medical HX, Blood/Saliva which will categorize by suspected hereditary predisposition: Based on family and medical history. - Sample stored in Biorepository

Higher Suspected Familial Predisposition Screening and Enrollment: Consent, Family HX, Medical HX, Blood/Saliva which will categorize by suspected hereditary predisposition: Based on family and medical history. - Specimen Testing and Analysis •Referral to Genetic Counselor, if indicated

Outcomes

Primary Outcome Measures

Number of participants who have childhood or suspected familial thyroid nodules/cancer

Number of germline mutations identified associated with thyroid cancer predisposition

Prevalence of suspected familial thyroid cancer among those with childhood thyroid nodules/cancer

Secondary Outcome Measures

Full Information

NCT ID

NCT02747888

First Posted

March 31, 2016

Last Updated

May 8, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT02747888

Brief Title

Hereditary Risk Factors for Thyroid Cancer

Official Title

Hereditary Risk Factors for Thyroid Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2016 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer

Keywords

Thyroid

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lower Suspected Familial Predisposition

Arm Type

No Intervention

Arm Description

Arm Title

Higher Suspected Familial Predisposition

Arm Type

Experimental

Arm Description

Intervention Type

Genetic

Intervention Name(s)

•Referral to Genetic Counselor, if indicated

Primary Outcome Measure Information:

Title

Number of participants who have childhood or suspected familial thyroid nodules/cancer

Time Frame

2 years

Title

Number of germline mutations identified associated with thyroid cancer predisposition

Time Frame

2 years

Title

Prevalence of suspected familial thyroid cancer among those with childhood thyroid nodules/cancer

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junne Kamihara, MD, PhD

Phone

617.632.3044

junne_kamihara@dfci.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Hunt, MPH

sarah_hunt@dfci.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junne Kamihara, MD, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junne Kamihara, MD, PhD

Phone

617-632-3044

First Name & Middle Initial & Last Name & Degree

Junne Kamihara, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Hereditary Risk Factors for Thyroid Cancer

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