NCT03676647

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
29mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Sep 2028

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
7.6 years until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

September 17, 2018

Last Update Submit

February 18, 2026

Conditions

Thyroid Gland Nodule

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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.

Other: Diagnostic DNA Methylation Signature

Interventions

Diagnostic DNA Methylation SignatureOTHER

Undergo collection of tissue samples

Also known as: DDMS
Diagnostic (biospecimen collection)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People undergoing fine needle aspiration.

You may qualify if:

  • 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 \[III-V\]).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Thyroid Nodule

Interventions

DDMS

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Maria Hahn, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

April 25, 2026

Primary Completion (Estimated)

September 25, 2028

Study Completion (Estimated)

September 25, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)