NCT05229341

Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,450 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value \[PPV\], negative predictive value \[NPV\], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules. SECONDARY OBJECTIVES: I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology. II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies. OUTLINE: Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Conditions

• Thyroid Gland Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Diagnostic Procedure	Analysis via DDMS-2
OTHER	Electronic Health Record Review	Review of medical records
PROCEDURE	Needle Biopsy	Undergo needle biopsy

Timeline

• Start date: 2021-10-22
• Primary completion: 2026-10-22
• Completion: 2026-10-22
• First posted: 2022-02-08
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States