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

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Brief Title

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

Official Title

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

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.

Detailed Description


      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.


      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.


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

Study Type


Primary Outcome

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


Thyroid Gland Carcinoma


Diagnostic Procedure

Study Arms / Comparison Groups

 Diagnostic (needle biopsy, DDMS-2)
Description:  Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 22, 2021

Completion Date

October 22, 2026

Primary Completion Date

October 22, 2026

Eligibility Criteria

        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




18 Years - N/A

Accepts Healthy Volunteers



John H Yim, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

City of Hope Medical Center


 National Cancer Institute (NCI)

Study Sponsor

John H Yim, Principal Investigator, City of Hope Medical Center

Verification Date

February 2022