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

NCT05846971 | Unknown

• 1 other identifier: 23-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus; Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Interventions

Educational materials on validated methylation assay OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Capsulomics, Inc.: lead

Study Sites (1)

Capsulomics, Inc.

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: May 6, 2023
• Study Start: January 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)