©2024 Stanford Medicine
Clinical Validation of ThyroidPrint: A Gene Expression Signature for Diagnosis of Indeterminate Thyroid Nodules
Recruiting
Trial ID: NCT03309631
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
Stanford Investigator(s)
Chris Holsinger, MD, FACS
Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Eligibility
Inclusion Criteria:
1. Patients undergoing FNA of a thyroid nodule.
2. Thyroid nodule greater 1cm
3. Age greater 18 years old.
Exclusion Criteria:
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.
Intervention(s):
diagnostic test: In vitro Diagnostic
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Chris Holsinger, MD