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

Esophageal Cancer Clinical Trial

— BEST-RPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335966
• Other study ID #: STUDY00025975
• Status: Recruiting
• Start date: January 25, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: Fouad Otaki, MD
• Phone: 503-494-4373
• Email: Otaki[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• Screening 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)

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Kuni Foundation, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Access: time to full diagnostic work up for patients with positive SECD results	Observe the time, effort, and barriers patients who live in rural areas with positive SECD tests experience to complete standard - diagnostic work up at tertiary care centers	8 months