Status:
NOT_YET_RECRUITING
Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Barrett Esophagus
Esophageal Adenocarcinoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This clinical trial studies how well minimally invasive approaches (an artificial intelligence \[AI\] powered risk tool, nurse navigation, and a sponge on a string \[SOS\] test) work in diagnosing pat...
Eligibility Criteria
Inclusion
- SPECIFIC AIM 1A: Adult patients 18-85 years old
- 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
- SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
1010 Patients enrolled
Trial Details
Trial ID
NCT07206589
Start Date
December 1 2025
End Date
October 31 2027
Last Update
October 21 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
3
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States, 54701