Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 6:27 PM
Study NCT ID:
NCT06335966
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2024-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the use of a SECD: Number of providers who indicate likelihood of using SECD', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Feasibility of the use of SECD: Number of providers who indicate willingness to be trained and train clinic staff', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Feasibility of the use of SECD: Number of referrals', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Feasibility of the use of SECD: Number enrolled', 'timeFrame': '8 months', 'description': 'Feasibility of screening for esophageal cancer via SECD in rural primary care settings will be measured by data collected from number of patients enrolled.'}, {'measure': 'Patient acceptability: Number of interested patients who schedule an appointment to be screened', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Patient acceptability: Number of patients who come to their appointments', 'timeFrame': '8 months', 'description': '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.'}, {'measure': 'Patient acceptability: Number of patients interested in being screened via SECD at other care centers', 'timeFrame': '8 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Access: time to full diagnostic work up for patients with positive SECD results', 'timeFrame': '8 months', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).\n\n* Chronic GERD Dx\n* 3 or more risk factors:\n\n * Male, age \\>50 years\n * White race\n * Tobacco smoking\n * Obesity\n * Family history of BE or EAC in a first-degree relative', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Willing and able to comply with the protocol\n* Live in a rural area\n* Chronic GERD Dx\n* 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\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06335966', 'acronym': 'BEST-RPP', 'briefTitle': 'BEST-RPP Pilot: Screening for Esophageal Cancer in Rural Oregon Without an Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': "Barrett's Esophagus Screening Towards Rural Referral Pathways: Screening for Esophageal Cancer in Rural Oregon Without Endoscopy", 'orgStudyIdInfo': {'id': 'STUDY00025975'}}, 'armsInterventionsModule': {'armGroups': [{'label': "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.", 'interventionNames': ['Device: Screening with swallowable esophageal cell-collection devices (SECD)']}], 'interventions': [{'name': 'Screening with swallowable esophageal cell-collection devices (SECD)', 'type': 'DEVICE', 'description': 'All participants who enroll in this study and provide their consent will undergo screening with an FDA approved swallowable esophageal cell-collection device (SECD)', 'armGroupLabels': ["Patients with suspected Barrett's Esophagus or at risk for esophageal cancer"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kuni Foundation', 'class': 'UNKNOWN'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fouad Otaki', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}