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Minimally Invasive Approaches for Barrett's Esophagus and Esophageal Cancer

This study, called the SOS5C Trial, is looking at new ways to find Barrett's esophagus (BE) and esophageal cancer early. BE is a condition where the lining of your esophagus (the tube that connects your mouth to your stomach) changes, which can sometimes lead to cancer. Researchers are testing three minimally invasive methods: an artificial intelligence (AI) tool to assess your risk, support from a nurse navigator, and a "sponge on a string" (SOS) test. The goal is to see how well these methods work together to diagnose these conditions. You might be able to join if you are between 18 and 85 years old and an AI risk tool shows you have a higher chance of having BE or esophageal cancer. The study will measure how many people complete the BE screening and how accurate the AI risk tool is.

Study design
This is an interventional study planning to enroll 1010 adult participants aged 18-85 years old.
What's involved
Participants will undergo a BE-SOS test, a computer-assisted BE risk assessment using an AI tool, an endoscopy (a procedure to look inside your esophagus), and a manual BE risk assessment. They will also receive nurse navigation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at baseline (completion of endoscopy).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07206589

Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial

Not Yet Recruiting
NAAges 18–85InterventionalScreening
Mayo Clinic
~1,010 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Cancer ScreeningComputer-Assisted InterventionEndoscopic ProcedureHealth Risk AssessmentNavigationQuestionnaire Administration

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of completed Barrett's esophagus (BE) screening
Measured over Baseline (completion of endoscopy)
+1 more outcome measured

Conditions

Barrett Esophagus
Esophageal Adenocarcinoma

Explore related trials

Barrett EsophagusEsophageal Adenocarcinoma

Where it's being run

3 sites across 3 states
Arizona1
Minnesota1
Wisconsin1

Study leadership

  • Prasad G Iyer, MD, MS · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Rate of completed Barrett's esophagus (BE) screeningBaseline (completion of endoscopy)

    Assessed as the proportion of patients who complete BE screening. This is determined as the number of patients who complete a sponge on a string (SOS) BE screening test or endoscopy screen, divided by the number of screen eligible patients in each group.

  • Negative predictive value of the AI powered BE Risk Tool (Aim 1b)Baseline (completion of endoscopy)

    A randomly selected sample of patients (N=50) with a negative BE risk tool score will undergo a research upper endoscopy to confirm the high estimated negative predicted value of the BE risk tool.