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Diagnostic Test

DNA Methylation Testing for Thyroid Nodules

N/A

Recruiting

Led By John H Yim

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to test for thyroid cancer using needle biopsies. The goal is to develop a more accurate test to avoid unnecessary surgeries for benign thyroid nodules.

Who is the study for?

This trial is for adults with thyroid nodules who are undergoing needle biopsies. Participants must be able to give informed consent and have the capacity to make decisions about their healthcare. Children are excluded because the biology of their thyroid nodules differs from that of adults.

What is being tested?

The study is testing a new diagnostic method using DNA methylation signatures from needle biopsy samples to distinguish between malignant (cancerous) and benign (non-cancerous) thyroid tumors, aiming to reduce unnecessary surgeries.

What are the potential side effects?

Since this trial involves reviewing electronic health records and performing standard diagnostic procedures like needle biopsies, side effects may include discomfort or bruising at the biopsy site, bleeding, infection risk, and very rarely damage to nearby structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mentally capable and scheduled for a thyroid biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am an adult.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Negative predictive value (NPV) of DDMS-2

Positive predictive value (PPV) of DDMS-2

Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (needle biopsy, DDMS-2)Experimental Treatment3 Interventions

Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

0 / 2Eligibility criteria met