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

City of Hope

Status: Enrolling

Conditions: Thyroid Gland Carcinoma

Treatments: Procedure: Needle Biopsy; Other: Electronic Health Record Review; Procedure: Diagnostic Procedure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05229341

21129 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2021-12556 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
• Over the age of 18
• Any gender, race and ethnicity
• Patients must provide informed consent prior to use of their tissues and clinical data

Exclusion criteria

• Children are excluded from the study, since the biology of children thyroid nodules is different from adults

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,450 participants in 1 patient group

Diagnostic (needle biopsy, DDMS-2)

Experimental group

Description:

Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Treatment:

Procedure: Diagnostic Procedure

Other: Electronic Health Record Review

Procedure: Needle Biopsy