About this trial
This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing FNA for thyroid nodule diagnosis.
Any race and ethnicity are eligible for the study.
Patient should have thyroid nodule(s) with indeterminate diagnosis after FNA (Bethesda category of indeterminate FNA [III-V]).
Disqualifiers
None
Trial population
People undergoing fine needle aspiration.
Trial design
Cohort
Other
Treatments tested in this trial
Diagnostic DNA Methylation Signature
Other interventionUndergo collection of tissue samples
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
Will be assessed by taking the ratio of the number of thyroid cancer specimens diagnosed as cancer using the DDMS and the total number of thyroid cancer specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Specificity of DDMS
Will be assessed by taking the ratio of the number of benign nodules diagnosed by DDMS and the total number of benign thyroid nodule specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Positive predictive value (PPV)
Will calculate PPV by dividing the number of true thyroid cancer specimens by the number of thyroid cancer diagnosis by DDMS. Will determine the 95% confidence intervals.
Negative predictive value (NPV)
Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will determine the 95% confidence intervals.
Sponsors and contacts
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator