NCT02747888

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2016Mar 2029

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 19, 2025

Status Verified

May 1, 2025

Enrollment Period

13 years

First QC Date

March 31, 2016

Last Update Submit

May 15, 2025

Conditions

Thyroid Cancer

Keywords

Thyroid

Outcome Measures

Primary Outcomes (3)

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

    2 years

  • Number of germline mutations identified associated with thyroid cancer predisposition

    2 years

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

    2 years

Study Arms (2)

Lower Suspected Familial Predisposition

NO INTERVENTION

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

EXPERIMENTAL

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

Genetic: •Referral to Genetic Counselor, if indicated

Interventions

•Referral to Genetic Counselor, if indicatedGENETIC
Higher Suspected Familial Predisposition

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • Individuals who are unable to give informed consent.
  • Individuals who are unable to complete study materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Study Officials

  • Junne Kamihara, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junne Kamihara, MD, PhD

CONTACT

617.632.3044junne_kamihara@dfci.harvard.edu

Sarah Hunt, MPH

CONTACT

sarah_hunt@dfci.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 22, 2016

Study Start

March 1, 2016

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

May 19, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)