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

City of Hope

Status: Enrolling

Conditions: Thyroid Gland Nodule

Treatments: Other: Diagnostic DNA Methylation Signature

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03676647

NCI-2018-01910 (Registry Identifier)

18077 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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]).

Trial design

22 participants in 1 patient group

Diagnostic (biospecimen collection)

Description:

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.

Treatment:

Other: Diagnostic DNA Methylation Signature