Esophageal CancerBEST-RPPNCT06335966
BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy
An observational study of Esophageal Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Screening with swallowable esophageal cell-collection devices (SECD)
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 6 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Screening with swallowable esophageal cell-collection devices (SECD)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Screening with swallowable esophageal cell-collection devices (SECD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (1)
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start11 Sep 2024
- Primary completion30 Dec 2024
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kuni Foundation, Oregon Health and Science University
- Responsible party
- Principal investigator, Fouad Otaki, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335966
- Sponsor's protocol ID
- STUDY00025975
- Acronym
- BEST-RPP
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy
- ClinicalTrials.gov ID
- NCT06335966
- Acronym / sponsor ID
- BEST-RPP / STUDY00025975
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Kuni Foundation, Oregon Health and Science University
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected Barrett's Esophagus or at risk for esophageal cancer | – | Device: Screening with swallowable esophageal cell-collection devices (SECD)Patients who receive primary care in a rural settings and are in need of screening for Barrett's Esophagus or esophageal cancer. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Patients with suspected Barrett's Esophagus or at risk for esophageal cancer |
Primary outcome
Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD
Time frame: 8 months
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.
Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff
Time frame: 8 months
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.
Feasibility of the use of SECD: Number of referrals
Time frame: 8 months
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.
Feasibility of the use of SECD: Number enrolled
Time frame: 8 months
Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of patients enrolled.
Patient acceptability: Number of interested patients who schedule an appointment to be screened
Time frame: 8 months
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.
Patient acceptability: Number of patients who come to their appointments
Time frame: 8 months
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.
Patient acceptability: Number of patients interested in being screened via SECD at other care centers
Time frame: 8 months
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.
1 secondary outcome
Access: time to full diagnostic work up for patients with positive SECD results
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD (time frame: 8 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.