Clinical trial NCT02747888: Hereditary Risk Factors for Thyroid Cancer
Official title: Hereditary Risk Factors for Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Keywords: Thyroid
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Number of participants who have childhood or suspected familial thyroid nodules/cancer
timeFrame: 2 years
measure: Number of germline mutations identified associated with thyroid cancer predisposition
timeFrame: 2 years
measure: Prevalence of suspected familial thyroid cancer among those with childhood thyroid nodules/cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Junne Kamihara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: