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

  • STATUS
    Recruiting
  • End date
    Oct 22, 2026
  • participants needed
    1450
  • sponsor
    City of Hope Medical Center
Updated on 24 March 2022

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 IdentifierNCT05229341
SponsorCity of Hope Medical Center
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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