Back to resultsClinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Primary Purpose
Barrett Esophagus, Esophageal Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational materials on validated methylation assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria: Be currently practicing board-certified gastroenterologist practicing in the United States Have practiced (as a board-certified gastroenterologist) for greater than 2 Be English-speaking Have ≥ 50 Barrett's esophagus patients under care annually Have Internet access Have no prior experience with the methylation assay test Provide voluntary informed consent to participate in the study. Exclusion Criteria: Non-practicing gastroenterologists Less than two years of gastroenterology practice Non-English speaking Does not have access to the internet Does not consent to participate in study
Sites / Locations
- Capsulomics, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
The control group will receive standard-of-care clinical data for their virtual patient cases. No educational material on the methylation assay will be provided.
The intervention group will receive standard-of-care clinical data for their virtual cases along with educational materials about the methylation assay. This group will then be provided with methylation assay data to be used in addition to clinical data.
Outcomes
Primary Outcome Measures
Clinical performance change in physician behavior.
Change in the overall and the diagnostic and treatment in patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants' diagnostic and treatment scores. In each category, participants' care recommendations are evaluated, ranging from 0 to a high potential score of up to 10, where higher scores mean increased intensity in surveillance and treatment, to measure the impact of the methylation assay on care decision making.
The impact of methylation assay on physician confidence in clinical care decision-making.
Measure the confidence in care decisions based on patient's methylation test result: Once the intervention group is exposed to the intervention, education materials on the methylation assay (a validated molecular test for risk stratifying patients with Barrett's esophagus), the scores are measured, on a scale of 0 to 10 from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the assay impacts confidence in the physician following evidence-based patient care.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05846971
Brief Title
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Official Title
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capsulomics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different clinical and prognostic assay information.
Detailed Description
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions for virtual patient cases when presented with different clinical and prognostic assay information. The data from this study will be published in a peer-review scientific journal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Esophageal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive standard-of-care clinical data for their virtual patient cases. No educational material on the methylation assay will be provided.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive standard-of-care clinical data for their virtual cases along with educational materials about the methylation assay. This group will then be provided with methylation assay data to be used in addition to clinical data.
Intervention Type
Other
Intervention Name(s)
Educational materials on validated methylation assay
Intervention Description
Educational materials include overall information on the assay including what the test does, how to use the test and report, and performance metrics on the test.
Primary Outcome Measure Information:
Title
Clinical performance change in physician behavior.
Description
Change in the overall and the diagnostic and treatment in patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants' diagnostic and treatment scores. In each category, participants' care recommendations are evaluated, ranging from 0 to a high potential score of up to 10, where higher scores mean increased intensity in surveillance and treatment, to measure the impact of the methylation assay on care decision making.
Time Frame
1 year
Title
The impact of methylation assay on physician confidence in clinical care decision-making.
Description
Measure the confidence in care decisions based on patient's methylation test result: Once the intervention group is exposed to the intervention, education materials on the methylation assay (a validated molecular test for risk stratifying patients with Barrett's esophagus), the scores are measured, on a scale of 0 to 10 from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the assay impacts confidence in the physician following evidence-based patient care.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be currently practicing board-certified gastroenterologist practicing in the United States
Have practiced (as a board-certified gastroenterologist) for greater than 2
Be English-speaking
Have ≥ 50 Barrett's esophagus patients under care annually
Have Internet access
Have no prior experience with the methylation assay test
Provide voluntary informed consent to participate in the study.
Exclusion Criteria:
Non-practicing gastroenterologists
Less than two years of gastroenterology practice
Non-English speaking
Does not have access to the internet
Does not consent to participate in study
Facility Information:
Facility Name
Capsulomics, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
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