Using a sponge capsule to detect Barrett's Esophagus and esophageal cancer

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

This study is testing a sponge capsule that can help find Barrett's Esophagus and esophageal cancer in people with and without chronic heartburn.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1550 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Scottsdale, Arizona and 8 other locations)
• Trial ID: NCT03961945 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a sponge capsule device in detecting Barrett's Esophagus and associated dysplasia or adenocarcinoma in patients with and without chronic gastroesophageal reflux disease. The SOS device will be administered by trained non-physicians, such as nurses, to collect esophageal cytology specimens. These specimens will then be analyzed for novel methylated DNA markers to improve diagnostic accuracy. The goal is to enhance early detection methods for these conditions in a screening population.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 50-85 with three or more risk factors for Barrett's Esophagus, who are primary care patients at Mayo Clinic.

Not a fit: Patients with a history of Barrett's esophagus or esophageal adenocarcinoma, or those who have had an endoscopy in the last five years, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of Barrett's Esophagus and esophageal adenocarcinoma, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using molecular approaches for early detection of esophageal conditions, but this specific method is relatively novel.

Eligibility 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.

Where this trial is running

Scottsdale, Arizona and 8 other locations

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (COMPLETED)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (COMPLETED)
• Mayo Clinic Health Systems - Austin — Austin, Minnesota, United States (RECRUITING)
• Mayo Clinic Health Systems - Mankato — Mankato, Minnesota, United States (COMPLETED)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (RECRUITING)
• Northwell Health — New Hyde Park, New York, United States (COMPLETED)
• Baylor Scott & White Research Institute — Dallas, Texas, United States (COMPLETED)
• Mayo Clinic Health System-Eau Claire — Eau Claire, Wisconsin, United States (RECRUITING)
• Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (WITHDRAWN)

Study contacts

• Principal investigator: Prasad G. Iyer, M.D. — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office

Conditions: Barrett Esophagus, Esophageal Adenocarcinoma, Barrett's Esophagus, Gastroesophageal Reflux, Reflux, Esophageal Cancer