Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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 and gene expression within the same prospective cohort of 800 indeterminate needle biopsies. OUTLINE: Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Official Title
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Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules

Conditions
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Thyroid Gland Carcinoma

Intervention / Treatment
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* Procedure: Diagnostic Procedure
* Other: Electronic Health Record Review
* Procedure: Needle Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (needle biopsy, DDMS-2)<br>Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed. | Procedure: Diagnostic Procedure<br>* Analysis via DDMS-2<br>* Other names: Diagnostic Test;Other: Electronic Health Record Review<br>* Review of medical records<br>Procedure: Needle Biopsy<br>* Undergo needle biopsy<br>* Other names: Puncture Biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2) | The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals. | Up to 5 years | 
| Specificity of DDMS-2 | The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals. | Up to 5 years | 
| Positive predictive value (PPV) of DDMS-2 | PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals. | Up to 5 years | 
| Negative predictive value (NPV) of DDMS-2 | NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals. | Up to 5 years |