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

Mayo Clinic

Status: Enrolling

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma

Treatments: Device: Sponge Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03961945

R01CA241164 (U.S. NIH Grant/Contract)

NCI-2021-14395 (Registry Identifier)

19-002629

Details and patient eligibility

About

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.

Full description

The sponge on a string (SOS) device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Enrollment: 1,550 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Aim1:

• Male and female ages 50-85

• Patients who have three or more risk factors for Barrett's Esophagus.

• Gastroesophageal reflux disease defined by:

  • Diagnosis
  • Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
  • prior endoscopic diagnosis of erosive esophagitis

• Body mass index (BMI) >= 30

Exclusion Criteria Aim1 and Aim 3:

• Previous history of:

  • esophageal adenocarcinoma/cancer
  • esophageal squamous carcinoma
  • endoscopic ablation for Barrett's esophagus
  • esophageal squamous dysplasia

• Current treatment with oral anticoagulation including Warfarin, Coumadin

• History of cirrhosis

• History of esophageal/gastric varices

• History of Barrett's esophagus

• Prior endoscopy in the last 5 years

Inclusion criteria Aim 2 and Aim 3:

• Subjects with known or suspected BE (cases).

  • Patient between the ages 18 - 90.
  • Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
  • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
  • Undergoing clinically indicated endoscopy.

• Subjects without known history of BE (controls).

  • Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria Aim 2:

• Subjects with known BE.

  • Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
  • Patients with history of esophageal resection for esophageal carcinoma.

• For subjects with or without known evidence of BE (on history or review of medical records):

  • Pregnant or lactating females.
  • Patients who are unable to consent.
  • Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
  • Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
  • Patients with history of known esophageal or gastric varices or cirrhosis.
  • Patients with history of surgical esophageal resection for esophageal carcinoma.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia.
  • Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
  • Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,550 participants in 3 patient groups

Screening Population

Other group

Description:

Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

Treatment:

Device: Sponge Capsule

Upper endoscopy - Barrett's Esophagus

Other group

Description:

Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Treatment:

Device: Sponge Capsule

Upper endoscopy - No Barrett's Esophagus

Other group

Description:

Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.

Treatment:

Device: Sponge Capsule