Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

Overview

About this study

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

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:

  • All participants will be 50 years of age or older and younger than 85 years of age. 
  • All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
  • Other risk factors considered would include:
    • Caucasian race;
    • History of ever smoking (current or prior history of smoking);
    • BMI greater than equal to 30;
    •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
    •  Male sex.

Exclusion Criteria:

  • History of Barrett's esophagus or esophageal adenocarcinoma.
  • Prior endoscopy in the last 10 years.
  • Pregnant or lactating females.
  • Patients who are unable to consent.
  • Patients with current history of uninvestigated dysphagia
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin.
  • Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients with history of known varices or cirrhosis.
  • Patients with history of esophageal or gastric resection.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
  • Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

 

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

Rochester, Minn.

Mayo Clinic principal investigator

Prasad Iyer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Sebastian Strobel, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Prabhjot Dosanjh, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Herbert Wolfsen, M.D.

Open for enrollment

Contact information:

Herbert Wolfsen M.D.

(904)953-6970

Wolfsen.Herbert@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Eduardo Antpack Filho, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Sushil Kumar Garg, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Francisco Ramirez, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20461792

Mayo Clinic Footer