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

NCT ID: NCT03676647

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-25

Study Completion Date

2028-09-25

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.

Conditions

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Thyroid Gland Nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Diagnostic DNA Methylation Signature

Intervention Type OTHER

Undergo collection of tissue samples

Interventions

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Diagnostic DNA Methylation Signature

Undergo collection of tissue samples

Intervention Type OTHER

Other Intervention Names

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DDMS

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 \[III-V\]).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Hahn, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Maria Hahn, PhD

Role: primary

626-256-4673

Other Identifiers

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NCI-2018-01910

Identifier Type: REGISTRY

Identifier Source: secondary_id

18077

Identifier Type: OTHER

Identifier Source: secondary_id

18077

Identifier Type: -

Identifier Source: org_study_id

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