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Clinical Validation of ThyroidPrint: A Gene Expression Signature for Diagnosis of Indeterminate Thyroid Nodules

NCT03309631 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2017-10-26

No results posted yet for this study

Summary

A clinical trial is proposed, to clinically validate, in a US population, the diagnostic performance of a new genetic test (ThyroidPrint). It will determine the nature of thyroid nodules that have been informed as indeterminate by cytology through a fine needle aspiration (FNA). The Genetic Classifier for Indeterminate Thyroid Nodules is a test that determines the expression of a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19, TIMP1, CLDN1, CAR, XB130, HO-1 and CCR7). Gene expression data is analyzed through an algorithm that generates a composite score that predicts the risk of malignancy. It´s intended use is for patients with thyroid cytology as indeterminate (Bethesda III and IV, according to The Bethesda System for Reporting Thyroid Cytopathology). This test uses a fine needle aspiration (FNA) sample.

Conditions

  • Indeterminate Thyroid Cytology

Interventions

DIAGNOSTIC_TEST

In vitro Diagnostic

Sponsors & Collaborators

  • Geneprodx

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Mark Zafareo, MD · M.D. Anderson Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2018-03-30
Completion
2018-06-30

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 NCT03309631 on ClinicalTrials.gov