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โ† Trials
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Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

RecruitingNAAges 18 Years - 90 YearsAllMayo Clinic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects with known or suspected Barrett's esophagus (BE) (cases) * Patients between the ages of 18-90. * Patients with a BE segment โ‰ฅ 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.
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What it tests

  • Cytosponge Procedure
  • Endoscopic Assessment
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Where

5 sites
Mayo Clinic
Scottsdale, United States
Mayo Clinic in Florida
Jacksonville, United States
Northwestern University
Chicago, United States
Mayo Clinic in Rochester
Rochester, United States
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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