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Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules

NCT03061318 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3100

Last updated 2017-10-31

No results posted yet for this study

Summary

A clinical trial is proposed, to clinically validate the diagnostic performance of a new genetic test developed in Chile. 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 quantitative gene expression test, that combines the results for a panel of 10 biomarkers (CXCR3, CCR3, CXCl10, CK19, TIMP1, CLDN1, CAR, XB130, HO-1 and CCR7), to generate a single number score. It is indicated on patients with a thyroid nodule informed by cytology as indeterminate (Bethesda III and IV, according to The Bethesda System for Reporting Thyroid Cytopathology). This test would be used by taking a sample with a fine needle aspiration (FNA) and thus, being able to predict, with high accuracy, benign nodules that do not require surgery.

Conditions

  • Indeterminate Thyroid Cytology

Sponsors & Collaborators

  • Hernán González

    lead OTHER

Principal Investigators

  • Hernán E González, MD · Pontificia Universidad Catolica de Chile

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-08
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • Chile

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 NCT03061318 on ClinicalTrials.gov