Using a swallowable sponge to collect esophageal samples for Barrett's esophagus detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the Cytosponge, a minimally invasive device, for collecting esophageal samples to detect Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC). Patients will either have known or suspected BE or will be controls without a history of BE, and will undergo sample collection followed by standard endoscopy. The study aims to measure DNA yield from the samples and assess the accuracy of the Oncoguard Esophagus test in identifying biomarkers for BE/EAC. Additionally, the tolerability of the Cytosponge device will be evaluated through patient surveys.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects with known or suspected Barrett's esophagus (BE) (cases)

  * Patients between the ages of 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:

* 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.
  * History of eosinophilic esophagitis, achalasia.
  * Patients on oral anticoagulation including Coumadin, Warfarin.
  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge 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 Cytosponge 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 it's running

• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Terminated
• Long Island Jewish Medical Center | Northwell Health
  New Hyde Park, New York, United States Completed

Study contacts

• Principal investigator: Prasad G. Iyer, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for patients undergoing esophageal cancer screening

  This study is collecting information from patients getting screened for Barrett Esophagus and Esophageal Adenocarcinoma using a new test to see how well it works and how patients feel about the process.

  Recruiting PAVmed Inc. · Lake Forest, California · NCT05965999

• Comparing surveillance and therapy for Barrett's esophagus with low-grade dysplasia

  This study is testing whether regular check-ups or a treatment to remove precancerous cells is better for people with Barrett's esophagus and low-grade dysplasia.

  Recruiting at 28 sites University of Colorado, Denver · Birmingham, Alabama and 29 other locations · NCT05753748

• Comparing two methods for sampling Barrett's esophagus

  This study is testing which method, the standard biopsy or a new sampling technique, is better at finding early signs of cancer in people with Barrett's esophagus.

  Recruiting at 14 sites University of Colorado, Denver · Gilbert, Arizona and 13 other locations · NCT05530343

• Itraconazole with endoscopic ablation to prevent esophageal cancer in high‑risk Barrett's esophagus

  This study tests if adding itraconazole to the standard endoscopic ablation can better prevent esophageal cancer in people with high-risk Barrett's esophagus.

  Recruiting at 4 sites Phase 2 National Cancer Institute (NCI) · Kansas City, Kansas and 5 other locations · NCT06732388

• Detecting Barrett's Esophagus in Patients Without GERD Symptoms

  This study is testing a new way to find Barrett's esophagus in people who don’t have GERD symptoms by using a simple capsule test instead of the usual endoscopy.

  Recruiting at 5 sites Case Comprehensive Cancer Center · Aurora, Colorado and 4 other locations · NCT06687603

• Assessing Barrett's Esophagus in Patients with Anorexia Nervosa and Purging Behaviors

  This study is trying to see if people with anorexia nervosa who purge have Barrett's esophagus, using non-invasive tests to check for this condition in patients aged 18-65.

  Recruiting at 3 sites Denver Health and Hospital Authority · Denver, Colorado and 2 other locations · NCT06532734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.