Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335966
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-08
Brief Title:
BEST-RPP Pilot Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Barretts Esophagus Screening Towards Rural Referral Pathways Screening for Esophageal Cancer in Rural Oregon Without Endoscopy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEST-RPP
Brief 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 Barretts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None