Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Primary Purpose
Thyroid Gland Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Procedure
Electronic Health Record Review
Needle Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Gland Carcinoma
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
Sites / Locations
- City of Hope Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (needle biopsy, DDMS-2)
Arm Description
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
Outcomes
Primary Outcome Measures
Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
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.
Specificity of DDMS-2
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.
Positive predictive value (PPV) of DDMS-2
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.
Negative predictive value (NPV) of DDMS-2
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05229341
First Posted
February 4, 2022
Last Updated
February 6, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05229341
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
October 22, 2026 (Anticipated)
Study Completion Date
October 22, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
Detailed Description
PRIMARY OBJECTIVE:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Gland Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (needle biopsy, DDMS-2)
Arm Type
Experimental
Arm Description
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic Procedure
Other Intervention Name(s)
Diagnostic Method, Diagnostic Technique, Diagnostic Test
Intervention Description
Analysis via DDMS-2
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Review of medical records
Intervention Type
Procedure
Intervention Name(s)
Needle Biopsy
Other Intervention Name(s)
Aspiration Biopsy, Puncture Biopsy
Intervention Description
Undergo needle biopsy
Primary Outcome Measure Information:
Title
Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
Description
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.
Time Frame
Up to 5 years
Title
Specificity of DDMS-2
Description
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.
Time Frame
Up to 5 years
Title
Positive predictive value (PPV) of DDMS-2
Description
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.
Time Frame
Up to 5 years
Title
Negative predictive value (NPV) of DDMS-2
Description
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.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Yim
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John H. Yim
Phone
626-218-3590
Email
JYim@coh.org
First Name & Middle Initial & Last Name & Degree
John H. Yim
12. IPD Sharing Statement
Learn more about this trial
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
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