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Active Not RecruitingNCT06335966

BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy

Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
110 (estimated)
Sponsor
OHSU Knight Cancer Institute · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

Summary

Recent advancements in swallowable esophageal cell-collection devices (SECD) offer a safe, minimally invasive, accurate, and low-cost alternative to esophageal screening without the need for an upper endoscopy. The BEST-RPP study aims to evaluate the acceptability and feasibility of using this novel approach to screen for Barrett's Esophagus (BE) and Esophageal Carcinoma (EAC) in rural primary care clinic settings in Oregon.

Detailed description

This is a proof-of-concept observational study to pilot the use of an FDA approved swallowable esophageal cell-collection device to screen for esophageal cancer in two rural primary care clinics in Oregon. The principal investigator will work with clinic staff to gauge the current use and understanding of SECDs as screening tools for esophageal cancer and to identify 50 patients at each site to approach about SECDs as an option for screening, for a total of 100 patients. If patients provide their consent and are eligible, they will undergo SECD administration for cancer screening in their primary care clinic. The study will evaluate the feasibility of use of this diagnostic tool in rural primary care settings, patient acceptability of screening for esophageal cancer via SECD in their primary care clinics, and where there are positive cases, the efficacy of diagnostic and treatment pathways to transitioning patients to tertiary centers for full diagnostic workup.

Conditions

Interventions

TypeNameDescription
DEVICEScreening with swallowable esophageal cell-collection devices (SECD)All participants who enroll in this study and provide their consent will undergo screening with an FDA approved swallowable esophageal cell-collection device (SECD)

Timeline

Start date
2024-09-11
Primary completion
2026-12-30
Completion
2026-12-30
First posted
2024-03-28
Last updated
2026-03-17

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06335966. Inclusion in this directory is not an endorsement.