Barrett Esophagus, Barretts Esophagus With Dysplasia, Esophagus Adenocarcinoma
Conditions
Brief summary
Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.
Interventions
DEVICEEsoGuard
EsoGuard is a set of genetic assays and algorithms for the assessment of specific methylation patterns of DNA encoding the genes vimentin (VIM) and cyclin A1 (CCNA1)
Sponsors
Lucid Diagnostics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG 2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.
Exclusion criteria
1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU) 2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening 3. Inability to provide written informed consent or participate in the required follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility | Through study completion, an average of 1 year | Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. This will be measured by asking physicians how the EsoGuard result impacted their referral decision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Compliance | Through study completion, an average of 1 year | Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results. This will be measured by collecting data on whether patients received an endoscopy after being referred. |
Countries
United States
Outcome results
None listed