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Diagnostic DNA Methylation Signature for Thyroid Cancer

This observational study is looking at how well a diagnostic DNA methylation signature (DDMS) can find thyroid cancer in people who have thyroid nodules. The DDMS is a test that looks at changes in your DNA. Researchers want to see if using the DDMS is a less invasive way to check for thyroid cancer. You may be able to join if you are 19 or older, have a thyroid nodule, and have had a fine-needle aspiration (FNA) that showed an uncertain result (Bethesda category III-V). The study will measure how accurately the DDMS can identify cancer (sensitivity and specificity) and how often a positive test truly means cancer (positive predictive value) over up to 5 years. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 22 participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo a fine-needle aspiration (FNA) to collect tissue samples for analysis using the DDMS assay. Previously collected FNA samples will also be analyzed.
Compensation
Not stated in the trial record.
Follow-up
After the study is completed, participants will be followed yearly for 5 years.

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NCT03676647

Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

Recruiting
Not specifiedAges 19+Observational
City of Hope Medical Center
~22 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Diagnostic DNA Methylation Signature

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
Measured over Up to 5 years
+3 more outcomes measured

Conditions

Thyroid Gland Nodule

Explore related trials

Thyroid Gland Nodule

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Maria Hahn, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Maria Hahn, PhD
[email protected]
626-256-4673
Email the study team

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Eligibility criteria

Inclusion

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 \[III-V\]).

What this trial measures

  • Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)Up to 5 years

    Will be assessed by taking the ratio of the number of thyroid cancer specimens diagnosed as cancer using the DDMS and the total number of thyroid cancer specimens according to the final diagnosis. Will determine the 95% confidence intervals.

  • Specificity of DDMSUp to 5 years

    Will be assessed by taking the ratio of the number of benign nodules diagnosed by DDMS and the total number of benign thyroid nodule specimens according to the final diagnosis. Will determine the 95% confidence intervals.

  • Positive predictive value (PPV)Up to 5 years

    Will calculate PPV by dividing the number of true thyroid cancer specimens by the number of thyroid cancer diagnosis by DDMS. Will determine the 95% confidence intervals.

  • Negative predictive value (NPV)Up to 5 years

    Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will determine the 95% confidence intervals.