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

Status unconfirmed

Conditions studied: Indeterminate Thyroid Cytology

In brief

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.

Key facts

Study ID

NCT03309631

Run by

Pontificia Universidad Catolica de Chile

People needed

1500

Starts

2016-03-01

Expected to finish

2018-06-30

Last updated by the study team

2017-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing FNA of a thyroid nodule.
• Thyroid nodule greater 1cm
• Age greater 18 years old.

You may not qualify if…

• Thyroid nodule greater 1cm
• Patients less than 18 years old,
• Previous history of coagulation disorders and patients.
• Ultrasound evidence of malignant cervical adenopathy.

Where it is running

• Avantt Research — Guntersville, Alabama, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Lee Moffit Cancer Center — Tampa, Florida, United States (enrolling)
• Tulane University — New Orleans, Louisiana, United States (enrolling)
• Universidad de Cincinnati — Cincinnati, Ohio, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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