Clinical trial NCT06335966: BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy
Official title: Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Kuni Foundation
name: Oregon Health and Science University
First posted: 2024-03-28
Enrollment: 110
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study seeks to enroll patients who: live in a rural area as defined by a Rural-Urban Commuting Area Code (RUCA) of greater than 4, are ages 50 years and above, and have screening as indicated by the American College of Gastroenterology recommendations for EAC (list below).

* Chronic GERD Dx
* 3 or more risk factors:

  * Male, age \>50 years
  * White race
  * Tobacco smoking
  * Obesity
  * Family history of BE or EAC in a first-degree relative

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 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD
timeFrame: 8 months
measure: Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff
timeFrame: 8 months
measure: Feasibility of the use of SECD: Number of referrals
timeFrame: 8 months
measure: Feasibility of the use of SECD: Number enrolled
timeFrame: 8 months
measure: Patient acceptability: Number of interested patients who schedule an appointment to be screened
timeFrame: 8 months
measure: Patient acceptability: Number of patients who come to their appointments
timeFrame: 8 months
measure: Patient acceptability: Number of patients interested in being screened via SECD at other care centers
timeFrame: 8 months
Secondary outcomes:
measure: Access: time to full diagnostic work up for patients with positive SECD results
timeFrame: 8 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
References: