NCT02352766|CompletedDMC
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · University of Pittsburgh
observational
256
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 15, 2019
Actual (reported)Study Completion
February 15, 2019
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 28, 2015
Actual (reported)February 2, 2015
Actual (reported)February 15, 2019
Actual (reported)February 15, 2019
Actual (reported)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
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.
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.)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Yuri Nikiforov, PhD, MD
University of Pittsburgh
256 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
PACE4 in Thyroid Cancer
Contact the study team to confirm eligibility.
Primary Completion
February 15, 2019
Actual (reported)Study Completion
February 15, 2019
Actual (reported)Last Updated
July 8, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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