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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01910 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18077 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (biospecimen collection) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic DNA Methylation Signature | Other | Undergo collection of tissue samples |
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| 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 |
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Inclusion Criteria:
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People undergoing fine needle aspiration.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hahn, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117975 | DDMS |
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Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |