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

Capsulomics

Status: Active, not recruiting

Conditions: Esophageal Cancer; Barrett Esophagus

Treatments: Other: Educational materials on validated methylation assay

Study type: Interventional

Funder types: Industry

Identifiers

NCT05846971

23-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control Group

No Intervention group

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.

Intervention Group

Experimental group

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.

Treatment:

Other: Educational materials on validated methylation assay