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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05229341
Collaborator
National Cancer Institute (NCI) (NIH)
1,450
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
24.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Diagnostic Procedure
  • Other: Electronic Health Record Review
  • Procedure: Needle Biopsy
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

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

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
Oct 22, 2026
Anticipated Study Completion Date :
Oct 22, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (needle biopsy, DDMS-2)

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
Analysis via DDMS-2
Other Names:
  • Diagnostic Method
  • Diagnostic Technique
  • Diagnostic Test

    • Other: Electronic Health Record Review
    Review of medical records

    Procedure: Needle Biopsy
    Undergo needle biopsy
    Other Names:
  • Aspiration Biopsy
  • Puncture Biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2) [Up to 5 years]

      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.

    2. Specificity of DDMS-2 [Up to 5 years]

      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.

    3. Positive predictive value (PPV) of DDMS-2 [Up to 5 years]

      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.

    4. Negative predictive value (NPV) of DDMS-2 [Up to 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT05229341
    Other Study ID Numbers:
    • 21129
    • NCI-2021-12556
    • 21129
    • P30CA033572
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Thyroid Nodule
    Thyroid Neoplasms
    Thyroid Diseases

    Study Results

    No Results Posted as of Feb 8, 2022