Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules

NCT05229341 | Recruiting DMC

• 3 other identifiers: 21129NCI-2021-12556P30CA033572
• Study Type: interventional
• Target: 1,450
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.

Conditions

Thyroid Gland Carcinoma

Outcome Measures

Primary Outcomes (4)

• Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)

  The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals.

  Up to 5 years

• Specificity of DDMS-2

  The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals.

  Up to 5 years

• Positive predictive value (PPV) of DDMS-2

  PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

  Up to 5 years

• Negative predictive value (NPV) of DDMS-2

  NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.

  Up to 5 years

Study Arms (1)

Diagnostic (needle biopsy, DDMS-2)

EXPERIMENTAL

Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Procedure: Diagnostic Procedure; Other: Electronic Health Record Review; Procedure: Needle Biopsy

Interventions

Diagnostic Procedure PROCEDURE

Analysis via DDMS-2

Also known as: Diagnostic Method, Diagnostic Technique, Diagnostic Test

Diagnostic (needle biopsy, DDMS-2)

Electronic Health Record Review OTHER

Review of medical records

Diagnostic (needle biopsy, DDMS-2)

Needle Biopsy PROCEDURE

Undergo needle biopsy

Also known as: Aspiration Biopsy, Puncture Biopsy

Diagnostic (needle biopsy, DDMS-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
• Over the age of 18
• Any gender, race and ethnicity
• Patients must provide informed consent prior to use of their tissues and clinical data

You may not qualify if:

• Children are excluded from the study, since the biology of children thyroid nodules is different from adults

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Molecular Diagnostic Techniques; Biopsy, Needle

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures

Study Officials

• John H Yim

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 8, 2022
• Study Start: October 22, 2021
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): October 22, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)