City of Hope Medical Center
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.
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 a…
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
Analysis via DDMS-2
Review of medical records
Undergo needle biopsy
Arctuva estimate
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