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

Trial ID or NCT#

NCT03309631

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Patients undergoing FNA of a thyroid nodule. 2. Thyroid nodule greater 1cm 3. Age greater 18 years old.
Exclusion Criteria:
  1. 1. Thyroid nodule greater 1cm 2. Patients less than 18 years old, 3. Previous history of coagulation disorders and patients. 4. Ultrasound evidence of malignant cervical adenopathy.
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Investigator(s)

Chris Holsinger, MD, FACS
Chris Holsinger, MD, FACS
Head and neck surgeon
Professor of Otolaryngology - Head & Neck Surgery (OHNS)

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Contact

Chris Holsinger, MD

View on ClinicalTrials.gov