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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Rate of completed Barrett's esophagus (BE) screening [Time frame: Baseline (completion of endoscopy)]
• Negative predictive value of the AI powered BE Risk Tool (Aim 1b) [Time frame: Baseline (completion of endoscopy)]

Secondary outcome measures (5)

• BE screening ordered (completed + not completed) [Time frame: Baseline (completion of endoscopy)]
• Successful completion of the SOS BE screen test [Time frame: Baseline (completion of endoscopy)]
• Completion of diagnostic endoscopy following a positive SOS BE screen test [Time frame: Baseline (completion of endoscopy)]
• Rates of BE [with or without dysplasia/esophageal adenocarcinoma (EAC)] [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 [Time frame: Baseline (completion of endoscopy)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 3 centers

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Rochester — Rochester
• Mayo Clinic Health System-Eau Claire Clinic — Eau Claire

Identifiers

NCT: NCT07206589 · SOS5C · R01CA241164 · 25-002435

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗