Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
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 a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureDiagnostic Procedure
Analysis via DDMS-2
- OtherElectronic Health Record Review
Review of medical records
- ProcedureNeedle Biopsy
Undergo needle biopsy
Location
- City of Hope Medical CenterDuarte, California