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

Active:	Yes
Cancer Type:	Thyroid Cancer	NCT ID:	NCT05229341
Trial Phases:		Protocol IDs:	21129 (primary) NCI-2021-12556
Eligibility:	18 Years and older, Male and Female	Study Type:	Diagnostic
Study Sponsor:	City of Hope Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT05229341

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.

Objectives

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. To 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 for genetic testing and may undergo thyroidectomy on study. Tissue samples are analyzed using DDMS-2.

After completion of study intervention, patients who do not undergo surgery are followed up at 4 years.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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