Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial
NCT ID: NCT07206589
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1010 participants
INTERVENTIONAL
2026-03-01
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
NCT07212491
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
NCT02560623
A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer
NCT06523374
Endoscopic Therapy of Early Cancer in Barretts Esophagus
NCT00217087
Stratifying Risk in Barrett's Esophagus: A Pilot Study for Biomarker-based Patient Management
NCT02075905
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 (T1 SOC, T2-T4 Intervention)
Family Medicine Care Teams in Cluster A provide SOC procedures during T1 consisting of the following: 1) Care teams manually assess BE risk for patients, and patients meeting ACG criteria are recommended to undergo BE screening with BE-SOS test followed by endoscopy (only if BE-SOS positive). Family Medicine Care Teams in Cluster A then provide intervention procedures during T2, T3, and T4 consisting of the following: 1) Care teams utilize RN navigators that assist in using the AI powered BE Risk Tool to assess patients' BE risk; 2) Patients with AI powered BE Risk Tool high risk result undergo BE-SOS test with RN navigator assistance; 3) Patients with positive BE-SOS test results then undergo endoscopy with RN navigator facilitation.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Arm 2 (T1 SOC, T2-T4 Intervention)
Family Medicine Care Teams in Cluster B provide SOC procedures as in Arm 1 during T1, followed by intervention procedures as in Arm 1 during T2, T3, and T4.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Arm 3 (T1-T2 SOC, T3-T4 Intervention)
Family Medicine Care Teams in Cluster C provide SOC procedures as in Arm 1 during T1 and T2, followed by intervention procedures as in Arm 1 during T3 and T4.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Arm 4 (T1-T2 SOC, T3-T4 Intervention)
Family Medicine Care Teams in Cluster D provide SOC procedures as in Arm 1 during T1 and T2, followed by intervention procedures as in Arm 1 during T3 and T4.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Arm 5 (T1-T3 SOC, T4 Intervention)
Family Medicine Care Teams in Cluster E provide SOC procedures as in Arm 1 during T1, T2, and T3, followed by intervention procedures as in Arm 1 during T4.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Arm 6 (T1-T3 SOC, T4 Intervention)
Family Medicine Care Teams in Cluster F provide SOC procedures as in Arm 1 during T1, T2, and T3, followed by intervention procedures as in Arm 1 during T4.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cancer Screening
Undergo BE-SOS test
Computer-Assisted Intervention
Undergo BE risk assessment using AI powered BE Risk Tool
Endoscopic Procedure
Undergo endoscopy
Health Risk Assessment
Undergo manual BE risk assessment
Navigation
Receive RN navigation
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score \> 0.087, indicating a higher risk for BE/esophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1.
* SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease \[GERD\]+ \> 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity \[body mass index (BMI) \> 30\], ever smoker, family history of BE/EAC)
* SPECIFIC AIM 1B: A "low risk" BE risk tool score (\< 0.0897)
Exclusion Criteria
* SPECIFIC AIM 1A: Prior endoscopy in the last 10 years
* SPECIFIC AIM 1A: Patients who are unable to consent
* SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia
* SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia
* SPECIFIC AIM 1A: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure
* SPECIFIC AIM 1A: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure
* SPECIFIC AIM 1A: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure
* SPECIFIC AIM 1A: Patients with a history of known varices or cirrhosis
* SPECIFIC AIM 1A: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
* SPECIFIC AIM 1A: Patients with congenital or acquired bleeding diatheses
* SPECIFIC AIM 1A: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma
* SPECIFIC AIM 1A: Patients with limited life expectancy (\< 2 years): per provider judgement
* SPECIFIC AIM 1B: History of Barrett's esophagus or esophageal adenocarcinoma
* SPECIFIC AIM 1B: Prior endoscopy in the last 10 years
* SPECIFIC AIM 1B: Patients who are unable to consent
* SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia
* SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia
* SPECIFIC AIM 1B: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure
* SPECIFIC AIM 1B: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure
* SPECIFIC AIM 1B: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure
* SPECIFIC AIM 1B: Patients with a history of known varices or cirrhosis
* SPECIFIC AIM 1B: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
* SPECIFIC AIM 1B: Patients with congenital or acquired bleeding diatheses
* SPECIFIC AIM 1B: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma
* SPECIFIC AIM 1B: Patients with limited life expectancy (\< 2 years): per provider judgement
18 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prasad G Iyer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2025-06682
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-002435
Identifier Type: OTHER
Identifier Source: secondary_id
SOS5C
Identifier Type: OTHER
Identifier Source: secondary_id
SOS5C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.