Clinical Validation of ThyroidPrint: A Gene Expression Signature for Diagnosis of Indeterminate Thyroid Nodules
Trial ID or NCT#
Status
NOT RECRUITING
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
- 1. Patients undergoing FNA of a thyroid nodule.2. Thyroid nodule greater 1cm3. Age greater 18 years old.
- 1. Thyroid nodule greater 1cm2. Patients less than 18 years old,3. Previous history of coagulation disorders and patients.4. Ultrasound evidence of malignant cervical adenopathy.
Investigator(s)
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Contact
Chris Holsinger, MD
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