Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
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
Mayo Clinic
400 participants
Oct 16, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria14
- 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.
Interventions
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06071845