Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
NCT ID: NCT05229341
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1450 participants
INTERVENTIONAL
2021-10-22
2026-10-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Diagnostic Procedure
Analysis via DDMS-2
Electronic Health Record Review
Review of medical records
Needle Biopsy
Undergo needle biopsy
Interventions
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Diagnostic Procedure
Analysis via DDMS-2
Electronic Health Record Review
Review of medical records
Needle Biopsy
Undergo needle biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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John H Yim
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2021-12556
Identifier Type: REGISTRY
Identifier Source: secondary_id
21129
Identifier Type: OTHER
Identifier Source: secondary_id
21129
Identifier Type: -
Identifier Source: org_study_id
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