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

Thyroid Gland Carcinoma Clinical Trial

Official title:

Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229341
• Other study ID #: 21129
• Secondary ID: NCI-2021-1255621
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: October 22, 2026

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value [PPV], negative predictive value [NPV], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules.

SECONDARY OBJECTIVES:

I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology.

II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies.

OUTLINE:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1450
• Est. completion date: October 22, 2026
• Est. primary completion date: October 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland Carcinoma
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Procedure:
• Diagnostic Procedure
Analysis via DDMS-2

Other:
• Electronic Health Record Review
Review of medical records

Procedure:
• Needle Biopsy
Undergo needle biopsy

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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