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

NCT02352766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 256

Last updated 2019-07-08

No results posted yet for this study

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • University of Cincinnati

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Yuri Nikiforov, PhD, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-02-15
Completion
2019-02-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352766 on ClinicalTrials.gov