Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
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- STATUS
- Recruiting
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- End date
- Oct 22, 2026
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- participants needed
- 1450
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- sponsor
- City of Hope Medical Center
Summary
This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.
Description
PRIMARY OBJECTIVE:
I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value [PPV], negative predictive value [NPV], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules.
SECONDARY OBJECTIVES:
I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology.
II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies.
- OUTLINE
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
Details
| Condition | Thyroid Gland Carcinoma |
|---|---|
| Treatment | needle biopsy, diagnostic procedure, Electronic Health Record Review |
| Clinical Study Identifier | NCT05229341 |
| Sponsor | City of Hope Medical Center |
| Last Modified on | 24 March 2022 |
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