Minimally Invasive Molecular Approaches For The Diagnosis Of Barrett’s Esophagus And Esophageal Adenocarcinoma

Overview

About this study

The purpose of this study is to Measure and compare BE screening rates with and without a multicomponent intervention, in a pragmatic cluster randomized trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult patients 18-85 years old.

  • Intervention clusters: BE Risk Tool Score > 0.087, indicating a higher risk for BE/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.

  • Control clusters: Meeting ACG screening criteria (GERD+ > 2 BE risk factors:: Age ≥ 50 years, Male sex, Caucasian race, obesity (BMI > 30), ever smoker, family history of BE/EAC)

Exclusion Criteria:

  • History of Barrett's esophagus or esophageal adenocarcinoma.
  • Prior endoscopy in the last 10 years.
  • Patients who are unable to consent.
  • Patients with a current history of uninvestigated dysphagia.
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure.
  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure.
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure.
  • Patients with a history of known varices or cirrhosis.
  • Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
  • Patients with limited life expectancy (< 2 years): per provider judgement.

Specific Aim 1b:

Inclusion Criteria:

  • a “low risk” BE risk tool score (< 0.0897)

Exclusion criteria:

  • History of Barrett's esophagus or esophageal adenocarcinoma.

  • Prior endoscopy in the last 10 years.

  • Patients who are unable to consent.

  • Patients with a current history of uninvestigated dysphagia.

  • History of eosinophilic esophagitis, achalasia.

  • Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure.

  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure.

  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/24/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Prasad Iyer, M.D., M.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available