Recruiting

ThyroidPrint

Sponsor:

Pontificia Universidad Catolica de Chile

Code:

NCT03309631

Conditions

Indeterminate Thyroid Cytology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

In vitro Diagnostic

Study Details

Brief summary:

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.

Conditions

Indeterminate Thyroid Cytology

Study ID

NCT03309631

Start date

Mar 1, 2016

Status verified date

Oct, 2017

Completion date

Jun 30, 2018

Anticipated

Primary completion date

Mar 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Interventions

In vitro Diagnostic

Primary outcome measure

  • Ability to predict Benign thyroid nodules. [ Time Frame: 24 months ]
  • Ability to predict Malignant thyroid nodules. [ Time Frame: 24 months ]
  • Sensitivity of the test [ Time Frame: 24 months ]
  • Specificity of the test [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Hernan E Gonzalez, MD, PhD

+56999734312hgonzale@med.puc.cl

Natalia Mena, PhD

56966770494natalia.paz.mensj@gmail.com

Locations

Avantt Research

Recruiting

Guntersville, Alabama, United States, 35976

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Lee Moffit Cancer Center

Recruiting

Tampa, Florida, United States

Tulane University

Recruiting

New Orleans, Louisiana, United States

Universidad de Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Pontificia Universidad Catolica de Chile

Last update posted

Oct 26, 2017

Last verified

Oct, 2017

Keywords

  • Gene classifier

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pontificia Universidad Catolica de Chile on 2017-10-26.