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Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05229341.
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.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationCity of Hope Comprehensive Cancer Center
