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Evaluating DNA Methylation Signatures for Thyroid Nodule Diagnosis

This study is looking into a new test called Diagnostic DNA Methylation Signatures (DDMS-2) to help diagnose thyroid nodules. The goal is to see if this test, which uses tissue from a needle biopsy, can accurately tell the difference between cancerous (malignant) and non-cancerous (benign) thyroid tumors. By doing this, the researchers hope to develop a more precise test that could help patients avoid unnecessary surgeries. You could be eligible if you are over 18, undergoing a needle biopsy for a thyroid nodule, and can provide informed consent. The study is currently unclear on its status and plans to enroll 1450 participants.

Study design
This interventional study aims to enroll 1450 participants to evaluate the DDMS-2 test.
What's involved
You would undergo a needle biopsy to collect tissue samples, and your medical records would be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 5 years after the diagnostic procedure.

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NCT05229341

Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

Recruiting
NAAges 18+InterventionalDiagnostic
City of Hope Medical Center
~1,450 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Diagnostic ProcedureElectronic Health Record ReviewNeedle Biopsy

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 Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
Measured over Up to 5 years
+3 more outcomes measured

Conditions

Thyroid Gland Carcinoma

Explore related trials

Thyroid Gland Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • John H Yim · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

John H. Yim
[email protected]
626-218-3590
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Children are excluded from the study, since the biology of children thyroid nodules is different from adults

What this trial measures

  • Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)Up to 5 years

    The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals.

  • Specificity of DDMS-2Up to 5 years

    The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals.

  • Positive predictive value (PPV) of DDMS-2Up to 5 years

    PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

  • Negative predictive value (NPV) of DDMS-2Up to 5 years

    NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.