Role of NGS-based ThyroSeq Panel in Cancer Diagnosis in Thyroid Nodules

NCT02352766 | Completed DMC

• 2 other identifiers: PRO14040164PITT 9006477
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, targeted next generation sequencing (NGS) platforms have been introduced that allow inexpensive testing for hundreds of mutational hotspots at the same time. A number of additional mutational markers in thyroid cancer have been identified. Highly promising markers associated with tumor prognosis have also been found. This multi-institutional study aims to validate the diagnostic use of mutational markers in thyroid nodules with indeterminate cytology. The proposed hypothesis is that a broad NGS-based genotyping of thyroid nodules using a large panel of mutational markers applied to thyroid FNA samples can provide an accurate cancer risk stratification in thyroid nodules. The performance of the panel will be tested in a multi-institutional double-blind prospective study of FNA samples from thyroid nodules with indeterminate cytology and available surgical outcome

Conditions

Thyroid Nodule

Keywords

Thyroid cancer; Thyroid nodules; Palpable nodules; FNA

Outcome Measures

Primary Outcomes (1)

• Primary outcomes

  The primary outcome measured in this study is the performance (sensitivity, specificity, NPV, PPV) of the Thyroseq Panel in diagnosing cancer in thyroid nodules with Bethesda III, VI and V cytology.

  April 2016

Study Arms (1)

Routine FNA for thyroid nodules

Patients that undergo a clinically diagnostic thyroid FNA will be asked by their clinician, who is a study co-investigator, if they are interested in participating in the research study. A small part of FNA material will be collected for molecular analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that undergo a routine diagnostic thyroid FNA that consent in participating in the research study whose samples have indeterminate cytologic diagnosis (Bethesda III, VI, or V) and surgical outcome are submitted for molecular testing. (Sample will be given a code that de-identifies the sample before it is sent to the testing laboratory. The lab that will analyze specimens is a CLIA certified Pitt lab.)

You may qualify if:

• Patients that undergo a clinically diagnostic thyroid FNA

You may not qualify if:

• Children
• pregnant women

Sponsors & Collaborators

• University of Pittsburgh: lead
• Duke University: collaborator
• Johns Hopkins University: collaborator
• Ohio State University: collaborator
• University of Cincinnati: collaborator
• University of Colorado, Denver: collaborator
• University of Pennsylvania: collaborator
• University of Wisconsin, Madison: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Yuri Nikiforov, PhD, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology; Vice Chair for Molecular Pathology

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

US (1)