Recruiting

Genomic Profiling

Sponsor:

Aventura Hospital and Medical Center

Code:

NCT03170804

Conditions

Thyroid Nodule

Thyroid Cancer

Thyroid Diseases

Thymic Carcinoma

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this registry is to collect uniform genomics-centered data on patients with nodular thyroid disease and cancer in a prospective fashion. After initial clinical evaluation patients with thyroid nodules will undergo standard ultrasonographic evaluation and a needle biopsy of the thyroid (fine needle aspiration (FNA) or core biopsy) as clinically indicated. Biopsy samples will be evaluated cyto-pathologically. A molecular/genomic profiling will be obtained using Thyroseq v2 test. Surgical treatment will be performed as per clinically determined indications. Standard surgical pathology will be processed and reported per the institutional policy and procedures. A molecular/genomic profiling will be obtained using Thyroseq v2 on the surgical specimen. All patients undergoing thyroid nodule work-up may be enrolled. The registry will collect patient demographic and clinical data, cytopathology reports, and surgical pathology reports and slides (if/when a review is required).

Conditions

Thyroid Nodule

Thyroid Cancer

Thyroid Diseases

Thymic Carcinoma

Study ID

NCT03170804

Start date

Jan 1, 2017

Status verified date

May, 2017

Completion date

Jan 1, 2020

Anticipated

Primary completion date

Jan 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients will be eligible for registry enrollment if they are undergoing thyroid nodule work-up.

Exclusion Criteria:

  • Patients will not be eligible for registry enrollment if a work-up beyond clinical evaluation is not indicated.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • prognostic value of Thyroseq v2 molecular/genomic profiling [ Time Frame: an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

Aventura Hospital and Medical Center

Recruiting

Aventura, Florida, United States, 33180

Contacts

More Information

Sponsor

Aventura Hospital and Medical Center

Last update posted

May 31, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aventura Hospital and Medical Center on 2017-05-31.