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NCT03061318: CT-DS

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

Completed Last updated 31 October 2017
What this trial tests

trial in Indeterminate Thyroid Cytology in 3,100 participants. Completed in 30 August 2017.

Timeline
8 August 2015
Primary endpoint
30 August 2017
30 August 2017

Quick facts

Lead sponsorHernán González
StatusCompleted
Study typeOBSERVATIONAL
Enrollment3,100
Start date8 August 2015
Primary completion30 August 2017
Estimated completion30 August 2017
Sites9 locations across Chile

Conditions studied

Sponsor

Hernán González

Who can join

18 and older, any sex, with Indeterminate Thyroid Cytology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Thyroid Genetic Classifier Correctly Predicts Benign Nodules with Indeterminate Cytology: Two Independent, Multicenter, Prospective Validation Trials.
    Zafereo M, McIver B, Vargas-Salas S, Domínguez JM, et al · · 2020 · cited 25× · PMID 31910118 · DOI 10.1089/thy.2019.0490

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