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

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• Cancer Screening — OTHER
  Undergo BE-SOS test
• Computer-Assisted Intervention — OTHER
  Undergo BE risk assessment using AI powered BE Risk Tool
• Endoscopic Procedure — PROCEDURE
  Undergo endoscopy
• Health Risk Assessment — BEHAVIORAL
  Undergo manual BE risk assessment
• Navigation — OTHER
  Receive RN navigation
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Apr 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

1,010 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Arm 1 (T1 SOC, T2-T4 Intervention)
  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.
• Experimental: Arm 2 (T1 SOC, T2-T4 Intervention)
  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.
• Experimental: Arm 3 (T1-T2 SOC, T3-T4 Intervention)
  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.
• Experimental: Arm 4 (T1-T2 SOC, T3-T4 Intervention)
  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.
• Experimental: Arm 5 (T1-T3 SOC, T4 Intervention)
  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.
• Experimental: Arm 6 (T1-T3 SOC, T4 Intervention)
  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.

Primary Outcome Measure

Rate of completed Barrett's esophagus (BE) screening [ Time Frame: Baseline (completion of endoscopy) ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]
• Ramona Lansing
  [email protected]

Locations (3)

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