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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Cytosponge Procedure

Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.

DIAGNOSTIC_TEST

Endoscopic Assessment

Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Locations (5)

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