Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. To validate a novel epigenetic thyroid nodule diagnostic test, diagnostic DNA methylation signature (DDMS) in a retrospective-prospective study with leftover of fine needle aspiration biopsies. OUTLINE: Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay. After completion of study, patients are followed up yearly for 5 years.

Official Title
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Retrospective-Prospective Collection of Thyroid Specimens After FNA

Conditions
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Thyroid Gland Nodule

Intervention / Treatment
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* Other: Diagnostic DNA Methylation Signature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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]).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (biospecimen collection)<br>Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay. | Other: Diagnostic DNA Methylation Signature<br>* Undergo collection of tissue samples<br>* Other names: DDMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years | 
| 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. | Up to 5 years | 
| 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. | Up to 5 years | 
| 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. | Up to 5 years |