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

NCT06335966 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00025975
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (7)

• Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD

  Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from Provider Post-Inservice Questionnaire, which includes, Indication of provider likelihood of using SECD as a screening tool.

  8 months

• Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff

  Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from Provider Post-Inservice Questionnaire, which includes, Indication of provider willingness to be trained and train clinic staff in SECD administration.

  8 months

• Feasibility of the use of SECD: Number of referrals

  Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of provider referrals received for the study.

  8 months

• Feasibility of the use of SECD: Number enrolled

  Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of patients enrolled.

  8 months

• Patient acceptability: Number of interested patients who schedule an appointment to be screened

  Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.

  8 months

• Patient acceptability: Number of patients who come to their appointments

  Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.

  8 months

• Patient acceptability: Number of patients interested in being screened via SECD at other care centers

  Assess patient acceptability of using a SECD for screening in rural primary care settings vs tertiary care centers Acceptability will be measured by the number of interested patients who schedule an appointment to be screened via the SECD and the number of patients who come to their appointments. As well as patients who are interested in being screened via SECD at other care centers where it is offered.

  8 months

Secondary Outcomes (1)

• Access: time to full diagnostic work up for patients with positive SECD results

  8 months

Study Arms (1)

Patients with suspected Barrett's Esophagus or at risk for esophageal cancer

Patients who receive primary care in a rural settings and are in need of screening for Barrett's Esophagus or esophageal cancer.

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

Interventions

Screening with swallowable esophageal cell-collection devices (SECD) DEVICE

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

Patients with suspected Barrett's Esophagus or at risk for esophageal cancer

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Signed informed consent
• Willing and able to comply with the protocol
• Live in a rural area
• Chronic GERD Dx
• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Kuni Foundation: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 28, 2024
• Study Start: September 11, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)