DNA methylation test for diagnosing thyroid nodules after fine-needle aspiration
Retrospective-Prospective Collection of Thyroid Specimens After FNA
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 |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT03676647 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are people undergoing fine-needle aspiration for thyroid nodules whose cytology is indeterminate (Bethesda category III–V).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Maria Hahn, PhD — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.