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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05229341
Status
Recruiting
Apply to this trial

Conditions

  • Thyroid Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 22, 2021
Status verified
Feb 2026
Primary completion
Oct 22, 2026
Completion
Oct 22, 2026

Study Design

Enrollment
1,450 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (needle biopsy, DDMS-2)
    Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Primary Outcome Measure

Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2) [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
John H. Yim
[email protected]
626-218-3590
John H. Yim (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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