DNA methylation test for diagnosing thyroid nodules after fine-needle aspiration
Official title: Retrospective-Prospective Collection of Thyroid Specimens After FNA
Run by City of Hope Medical Center · NCT03676647 · Data updated 2026-11-12
This test tries a DNA methylation signature to detect cancer in people with thyroid nodules who have indeterminate fine-needle aspiration results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | January 1, 2027 |
| Main results expected | September 25, 2028 |
| Study ends | September 25, 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT03676647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people undergoing fine-needle aspiration for thyroid nodules whose cytology is indeterminate (Bethesda category III–V).
✕Probably not a fit
Patients with clearly benign or clearly malignant cytology, those who do not undergo FNA, or samples that are insufficient for analysis are unlikely to benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project applies a diagnostic DNA methylation signature (DDMS) to leftover and newly collected fine-needle aspiration (FNA) samples from patients with thyroid nodules to determine whether methylation patterns distinguish benign from malignant lesions. It combines retrospective analysis of previously collected FNA specimens with prospective collection from current patients, analyzing all samples using the DDMS assay. Participants whose samples are tested are followed yearly for five years to track clinical outcomes and confirm diagnoses. The primary goal is to validate the DDMS as a diagnostic tool specifically for nodules with indeterminate cytology (Bethesda III–V).
Why it matters
Potential benefit: If successful, the test could reduce unnecessary diagnostic surgery by providing a less invasive way to identify cancer in indeterminate thyroid nodules.
How similar studies have gone: Other molecular classifiers for thyroid nodules (such as genomic expression or mutation panels) have improved diagnostic accuracy, while methylation-based diagnostics are a newer approach with limited but promising supporting data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \[III-V\]).
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Principal investigator: Maria Hahn, PhD — City of Hope Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.