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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05846971
• Other study ID #: 23-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Capsulomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer

Intervention

Other:
• Educational materials on validated methylation assay
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.

Locations

Country	Name	City	State
United States	Capsulomics, Inc.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Capsulomics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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