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

Thyroid Gland Nodule Clinical Trial

Official title:

Retrospective-Prospective Collection of Thyroid Specimens After FNA

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03676647
• Other study ID #: 18077
• Secondary ID: NCI-2018-0191018
• Status: Withdrawn
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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]).

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland Nodule
• Thyroid Nodule

Intervention

Other:
• Diagnostic DNA Methylation Signature
Undergo collection of tissue samples

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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