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NCT Number: NCT07206589

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

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.

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Key information

Conditions

Barrett Esophagus Adenocarcinoma Of Esophagus Digestive System Diseases Esophageal Adenocarcinoma Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Cancer Screening

Other

Undergo BE-SOS test

Other names: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer

Computer-Assisted Intervention

Other

Undergo BE risk assessment using AI powered BE Risk Tool

Endoscopic Procedure

Procedure

Undergo endoscopy

Other names: Endoscopic Examination, Endoscopy, ES

Health Risk Assessment

Behavioral

Undergo manual BE risk assessment

Other names: Risk Assessment

Navigation

Other

Receive RN navigation

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Rate of completed Barrett's esophagus (BE) screening

    Time frame: Baseline (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.

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

    Time frame: 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.

Secondary outcomes

  1. BE screening ordered (completed + not completed)

    Time frame: Baseline (completion of endoscopy)

    Assessed as the proportion of patients who complete BE screening (SOS BE screen test or endoscopy) for patients where BE screening has been ordered.

  2. Successful completion of the SOS BE screen test

    Time frame: Baseline (completion of endoscopy)

    Assessed as the number that had successful test completion (a test result was received) divided by the number of patients where a BE-SOS test/endoscopy order was placed

  3. Completion of diagnostic endoscopy following a positive SOS BE screen test

    Time frame: Baseline (completion of endoscopy)

    Assessed as the proportion of patients who complete diagnostic endoscopy following a positive BE-SOS test.

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

    Time frame: Baseline (completion of endoscopy)

    The proportion of patients with BE/EAC diagnoses will be determined as the number with a BE/EAC diagnosis divided by the number of patients who underwent BE-SOS or endoscopy.

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

    Time frame: Baseline (completion of endoscopy)

    The proportion of screen eligible patients in the intervention arm who meet ACG screening criteria will be determined as the number meeting screening criteria divided by the number in the group.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Ramona Lansing

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 3, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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