Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus

Conditions
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Barrett Esophagus, Esophageal Cancer

Intervention / Treatment
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* Other: Educational materials on validated methylation assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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. | |
| Experimental: Intervention Group<br>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. | Other: Educational materials on validated methylation assay<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 
| 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. | 1 year |