An interventional study of Cancer Screening and Computer-Assisted Intervention in Barrett Esophagus and Esophageal Adenocarcinoma, sponsored by Mayo Clinic. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Screening
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.
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's planned enrollment of 1,010 is above the median of 62 across 186 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
Undergo BE-SOS test
Also known as: Cancer Screening for Patients, Early Cancer Detection, Screening, Screening of Cancer
Undergo BE risk assessment using AI powered BE Risk Tool
Undergo endoscopy
Also known as: Endoscopic Examination, Endoscopy, ES
Undergo manual BE risk assessment
Also known as: Risk Assessment
Receive RN navigation
Ancillary studies
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.
Time frame: 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.
Time frame: Baseline (completion of endoscopy)
BE screening ordered (completed + not completed)
Assessed as the proportion of patients who complete BE screening (SOS BE screen test or endoscopy) for patients where BE screening has been ordered.
Time frame: Baseline (completion of endoscopy)
Successful completion of the SOS BE screen test
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
Time frame: Baseline (completion of endoscopy)
Completion of diagnostic endoscopy following a positive SOS BE screen test
Assessed as the proportion of patients who complete diagnostic endoscopy following a positive BE-SOS test.
Time frame: Baseline (completion of endoscopy)
Rates of BE [with or without dysplasia/esophageal adenocarcinoma (EAC)]
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.
Time frame: 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
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.
Time frame: Baseline (completion of endoscopy)
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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