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

OHSU Knight Cancer Institute logo

OHSU Knight Cancer Institute

Status

Active, not recruiting

Conditions

Esophageal Cancer

Treatments

Device: Screening with swallowable esophageal cell-collection devices (SECD)

Study type

Observational

Funder types

Other

Identifiers

NCT06335966
STUDY00025975

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent
  • Willing and able to comply with the protocol
  • Live in a rural area
  • Chronic GERD Dx
  • 3 or more of the following risk factors: Male, age >50 years White race Tobacco smoking Obesity Family history of BE or EAC in a first-degree relative

Exclusion criteria

-

Trial design

110 participants in 1 patient group

Patients with suspected Barrett's Esophagus or at risk for esophageal cancer
Description:
Patients who receive primary care in a rural settings and are in need of screening for Barrett's Esophagus or esophageal cancer.
Treatment:
Device: Screening with swallowable esophageal cell-collection devices (SECD)

Trial contacts and locations

1

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Central trial contact

Fouad Otaki, MD; Laura Ferrara, MA

Data sourced from clinicaltrials.gov

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