Recruiting

DNA Methylation

Sponsor:

City of Hope Medical Center

Code:

NCT05229341

Conditions

Thyroid Gland Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diagnostic Procedure

Electronic Health Record Review

Needle Biopsy

Study Details

Brief 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.

Conditions

Thyroid Gland Carcinoma

Study ID

NCT05229341

Start date

Oct 22, 2021

Status verified date

Feb, 2026

Completion date

Oct 22, 2026

Anticipated

Primary completion date

Oct 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Diagnostic Procedure

Analysis via DDMS-2

Electronic Health Record Review

Review of medical records

Needle Biopsy

Undergo needle biopsy

Primary outcome measure

  • Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2) [ Time Frame: Up to 5 years ]
  • Specificity of DDMS-2 [ Time Frame: Up to 5 years ]
  • Positive predictive value (PPV) of DDMS-2 [ Time Frame: Up to 5 years ]
  • Negative predictive value (NPV) of DDMS-2 [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

John H. Yim

626-218-3590JYim@coh.org

Principal Investigator:

John H. Yim

More Information

Sponsor

City of Hope Medical Center

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-02-23.