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Trial Title:
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
NCT ID:
NCT05846971
Condition:
Barrett Esophagus
Esophageal Cancer
Conditions: Official terms:
Barrett Esophagus
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Other
Intervention name:
Educational materials on validated methylation assay
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.
Arm group label:
Intervention Group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Capsulomics, Inc.
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Start date:
January 26, 2021
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Capsulomics, Inc.
Agency class:
Industry
Source:
Capsulomics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05846971
