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Tests minimally invasive methods to screen for Barrett's esophagus and esophageal cancer

Tests an AI risk tool, nurse navigation and a swallowable cell sponge test in adults.

Key facts

Who runs it
Mayo Clinic
Where
Eau Claire, Rochester, and Scottsdale, United StatesSee the 3 sites
Trial code
Registry title
Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial
Status
Not yet recruiting
People taking part
1,010 people, planned
Starts
1 Dec 2026
Expected to end
31 Jul 2030
Type of study
Interventional, 6 groups
Treatments tested
  • Cancer Screening
  • Computer-Assisted Intervention
  • Endoscopic Procedure
  • Health Risk Assessment
  • Navigation
  • Questionnaire Administration
Record updated
24 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 85 who are at higher risk of Barrett's esophagus or esophageal cancer, or at low risk by a risk tool score. It tests minimally invasive ways to find these conditions.

Age
18 to 85 years
Sex
All sexes can join.
Disease stage
No Barrett's esophagus or esophageal adenocarcinoma yet. Higher risk is a BE Risk Tool score above 0.087 or meeting American College of Gastroenterology screening criteria. One part asks for a low-risk score below 0.0897.
Earlier treatment
No endoscopy in the last 10 years. Blood thinners must be stopped for five days before the procedure.
Biomarker or test result
A BE Risk Tool score, calculated from electronic health record data, is used. The score runs from 0 to 1.

Main reasons for not taking part

  • History of Barrett's esophagus or esophageal adenocarcinoma
  • Endoscopy in the last 10 years
  • Unable to consent
  • Uninvestigated trouble swallowing, eosinophilic esophagitis or achalasia
  • Known varices or cirrhosis, bleeding disorders, or limited life expectancy under 2 years

The registry criteria, word for word

Show all 30 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • SPECIFIC AIM 1A: Prior endoscopy in the last 10 years
  • 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 1B: Prior endoscopy in the last 10 years
  • 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 1A: History of Barrett's esophagus or esophageal adenocarcinoma
  • SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia
  • SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia
  • 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 1B: History of Barrett's esophagus or esophageal adenocarcinoma
  • SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia
  • SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia
  • 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 1A: Patients with limited life expectancy (< 2 years): per provider judgement
  • SPECIFIC AIM 1B: Patients with limited life expectancy (< 2 years): per provider judgement
  • SPECIFIC AIM 1A: Patients who are unable to consent
  • SPECIFIC AIM 1B: Patients who are unable to consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in United States

  • Mayo Clinic Health System-Eau Claire ClinicEau Claire, United StatesContact: Clinical Trials Referral OfficeNot yet recruiting
  • Mayo Clinic in RochesterRochester, United StatesContact: Clinical Trials Referral OfficeNot yet recruiting
  • Mayo Clinic in ArizonaScottsdale, United StatesContact: Clinical Trials Referral OfficeNot yet recruiting

About the trial

What the trial wants to find out

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 patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age > 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.

The 6 groups in the trial

  • Arm 1 (T1 SOC, T2-T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

  • Arm 2 (T1 SOC, T2-T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

  • Arm 3 (T1-T2 SOC, T3-T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

  • Arm 4 (T1-T2 SOC, T3-T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

  • Arm 5 (T1-T3 SOC, T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

  • Arm 6 (T1-T3 SOC, T4 Intervention)Treatment being tested

    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.

    Treatment: Cancer Screening, Computer-Assisted Intervention, Endoscopic Procedure, Health Risk Assessment, Navigation, and Questionnaire Administration

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)
Plain-language title
Tests minimally invasive methods to screen for Barrett's esophagus and esophageal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07206589, who can take part
Record updated
24 June 2026