Recruiting

DNA Methylation Signature

Sponsor:

City of Hope Medical Center

Code:

NCT03676647

Conditions

Thyroid Gland Nodule

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Diagnostic DNA Methylation Signature

Study Details

Brief summary:

This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.

Conditions

Thyroid Gland Nodule

Study ID

NCT03676647

Start date

Jan 1, 2027

Status verified date

Jun, 2026

Completion date

Sep 25, 2028

Anticipated

Primary completion date

Sep 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients undergoing FNA for thyroid nodule diagnosis.
  • Any race and ethnicity are eligible for the study.
  • Patient should have thyroid nodule(s) with indeterminate diagnosis after FNA (Bethesda category of indeterminate FNA \[III-V\]).

Study Design

Enrollment

22 participants

Anticipated

Interventions and Outcome Measures

Arms

Diagnostic (biospecimen collection)

Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.

Interventions

Diagnostic DNA Methylation Signature

Undergo collection of tissue samples

Primary outcome measure

  • Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS) [ Time Frame: Up to 5 years ]
  • Specificity of DDMS [ Time Frame: Up to 5 years ]
  • Positive predictive value (PPV) [ Time Frame: Up to 5 years ]
  • Negative predictive value (NPV) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Maria Hahn, PhD

626-256-4673mhahn@coh.org

Principal Investigator:

Maria Hahn

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jun 2, 2026

Last verified

Jun, 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 2026-06-02.