Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
Purpose
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.
Condition
- Thyroid Gland Nodule
Eligibility
- Eligible Ages
- Over 19 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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]).
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Duarte, California 91010
More Details
- Status
- Recruiting
- Sponsor
- City of Hope Medical Center
Study Contact
Detailed Description
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.