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

Not Applicable

Active, not recruiting

• Conditions: Barrett Esophagus; Esophageal Cancer
• Interventions: Other: Educational materials on validated methylation assay

• Registration Number: NCT05846971
• Lead Sponsor: Capsulomics, Inc.

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.

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2022-11-14
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Be currently practicing board-certified gastroenterologist practicing in the United States
2. Have practiced (as a board-certified gastroenterologist) for greater than 2
3. Be English-speaking
4. Have ≥ 50 Barrett's esophagus patients under care annually
5. Have Internet access
6. Have no prior experience with the methylation assay test
7. Provide voluntary informed consent to participate in the study.

Exclusion Criteria

1. Non-practicing gastroenterologists
2. Less than two years of gastroenterology practice
3. Non-English speaking
4. Does not have access to the internet
5. Does not consent to participate in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Educational materials on validated methylation assay	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.

Primary Outcome Measures

Name	Time	Method
Clinical performance change in physician behavior.	1 year	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.	1 year	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.

Trial Locations

Locations (1)

Capsulomics, Inc.; 🇺🇸 Baltimore, Maryland, United States