Actively Recruiting
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Led by Mayo Clinic · Updated on 2025-12-16
400
Participants Needed
5
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
CONDITIONS
Official Title
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 90 years
- Patients with known or suspected Barrett's esophagus
- Barrett's esophagus segment of at least 1 cm in maximal endoscopic extent or suspected BE in medical records
- Histology showing intestinal metaplasia with or without dysplasia, or suspected BE in medical records
- Patients undergoing clinically indicated endoscopy
- Patients without known Barrett's esophagus undergoing clinically indicated diagnostic endoscopy
You will not qualify if you...
- Pregnant or breastfeeding females
- Patients unable to provide consent
- Patients with current uninvestigated dysphagia
- History of eosinophilic esophagitis or achalasia
- Patients on oral anticoagulants such as Coumadin or Warfarin
- Patients on antiplatelet agents like Clopidogrel unless discontinued 3-5 days before Cytosponge
- Patients on oral thrombin inhibitors or factor Xa inhibitors unless discontinued 3-5 days before Cytosponge
- History of esophageal or gastric varices or cirrhosis
- History of surgical esophageal resection for esophageal cancer
- Patients with congenital or acquired bleeding disorders
- History of esophageal squamous dysplasia
- Known foregut carcinoma (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years
- Patients who received chemotherapy or radiation for mediastinal or esophageal cancer
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Terminated
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, United States, 11040
Completed
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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