Using a swallowable sponge to collect esophageal samples for Barrett's esophagus detection
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
This study is testing a swallowable sponge to see if it can safely collect samples from the esophagus to help detect Barrett's esophagus and esophageal cancer in patients who may have these conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Trial ID | NCT06071845 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with known or suspected Barrett's esophagus or those undergoing clinically indicated endoscopy without a history of BE.
Not a fit: Patients who are pregnant, unable to consent, or have certain esophageal conditions or are on specific anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a simpler and more cost-effective method for early detection of Barrett's esophagus and esophageal adenocarcinoma.
How similar studies have performed: Other studies have shown promise with similar non-endoscopic approaches for Barrett's esophagus screening, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona and 4 other locations
- Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Terminated)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.