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Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial
Trial Status: approved
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT07206589.
I. Measure and compare BE screening rates with and without a multicomponent intervention, in a pragmatic cluster randomized trial.
OUTLINE: Family Medicine Care Team clusters are randomized to 1 of 6 arms.
ARM 1: Family Medicine Care Teams in Cluster A provide standard of care (SOC) procedures during months 0-6 (Time [T]1) consisting of the following: 1) Care teams manually assess BE risk for patients, and patients meeting American College of Gastroenterology (ACG) criteria are recommended to undergo BE screening with BE-sponge on a string (SOS) test followed by endoscopy (only if BE-SOS positive). Family Medicine Care Teams in Cluster A then provide intervention procedures during months 7-12 (T2), 13-18 (T3), and 19-24 (T4) consisting of the following: 1) Care teams utilize Registered Nurse (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.
ARM 2: 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.
ARM 3: 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.
ARM 4: 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.
ARM 5: 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.
ARM 6: 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.
