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Trial record 2 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

Hereditary Risk Factors for Thyroid Cancer

This study is currently recruiting participants.
Verified July 2017 by Junne Kamihara, Dana-Farber Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02747888
First Posted: April 22, 2016
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Junne Kamihara, Dana-Farber Cancer Institute
  Purpose

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.

Condition Intervention
Thyroid Cancer Genetic: •Referral to Genetic Counselor, if indicated

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Hereditary Risk Factors for Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Junne Kamihara, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Number of participants who have childhood or suspected familial thyroid nodules/cancer [ Time Frame: 2 years ]
  • Number of germline mutations identified associated with thyroid cancer predisposition [ Time Frame: 2 years ]
  • Prevalence of suspected familial thyroid cancer among those with childhood thyroid nodules/cancer [ Time Frame: 2 years ]

Estimated Enrollment: 165
Actual Study Start Date: March 1, 2016
Estimated Study Completion Date: March 1, 2021
Estimated Primary Completion Date: March 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lower Suspected Familial Predisposition

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

Experimental: Higher Suspected Familial Predisposition

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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747888


Contacts
Contact: Junne Kamihara, MD, PhD 617.632.3044

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Junne Kamihara, MD, PhD    617-632-3044      
Principal Investigator: Junne Kamihara, MD, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Junne Kamihara, MD, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Junne Kamihara, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02747888     History of Changes
Other Study ID Numbers: 15-159
First Submitted: March 31, 2016
First Posted: April 22, 2016
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Junne Kamihara, Dana-Farber Cancer Institute:
Thyroid

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms