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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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]).

Disqualifiers

None

Trial population

People undergoing fine needle aspiration.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Diagnostic DNA Methylation Signature

    Other intervention

    Undergo collection of tissue samples

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Diagnostic (biospecimen collection)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 5 years
2

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.

Time frame
Up to 5 years
3

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.

Time frame
Up to 5 years
4

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.

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator