Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
18 Years and older, Male and Female
21129 (primary)
NCI-2021-12556
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.
Eligibility
- 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
Treatment Sites in Georgia
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