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

NCT07206589 | Not Yet Recruiting

• 3 other identifiers: SOS5CR01CA24116425-002435
• Study Type: interventional
• Target: 1,010
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Rate of completed Barrett's esophagus (BE) screening

  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.

  Baseline (completion of endoscopy)

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

  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.

  Baseline (completion of endoscopy)

Secondary Outcomes (5)

• BE screening ordered (completed + not completed)

  Baseline (completion of endoscopy)

• Successful completion of the SOS BE screen test

  Baseline (completion of endoscopy)

• Completion of diagnostic endoscopy following a positive SOS BE screen test

  Baseline (completion of endoscopy)

• Rates of BE [with or without dysplasia/esophageal adenocarcinoma (EAC)]

  Baseline (completion of endoscopy)

• Patients flagged for screening by the BE risk tool in the intervention clusters who also meet American College of Gastroenterology (ACG) BE screening guidelines

  Baseline (completion of endoscopy)

Study Arms (6)

Arm 1 (T1 SOC, T2-T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Arm 2 (T1 SOC, T2-T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Arm 3 (T1-T2 SOC, T3-T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Arm 4 (T1-T2 SOC, T3-T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Arm 5 (T1-T3 SOC, T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Arm 6 (T1-T3 SOC, T4 Intervention)

EXPERIMENTAL

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.

Other: Cancer Screening; Other: Computer-Assisted Intervention; Procedure: Endoscopic Procedure; Behavioral: Health Risk Assessment; Other: Navigation; Other: Questionnaire Administration

Interventions

Cancer Screening OTHER

Undergo BE-SOS test

Also known as: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Computer-Assisted Intervention OTHER

Undergo BE risk assessment using AI powered BE Risk Tool

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Endoscopic Procedure PROCEDURE

Undergo endoscopy

Also known as: Endoscopic Examination, Endoscopy, ES

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Health Risk Assessment BEHAVIORAL

Undergo manual BE risk assessment

Also known as: Risk Assessment

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Navigation OTHER

Receive RN navigation

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (T1 SOC, T2-T4 Intervention); Arm 2 (T1 SOC, T2-T4 Intervention); Arm 3 (T1-T2 SOC, T3-T4 Intervention); Arm 4 (T1-T2 SOC, T3-T4 Intervention); Arm 5 (T1-T3 SOC, T4 Intervention); Arm 6 (T1-T3 SOC, T4 Intervention)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Interventions

Mass Screening; Endoscopy; Risk Assessment

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Risk; Probability; Statistics as Topic; Risk Management; Organization and Administration; Health Services Administration; Epidemiologic Measurements

Study Officials

• Prasad G Iyer, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Ramona Lansing

CONTACT

lansing.ramona@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (3)