Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples (NCT06071845) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
United States400 participantsStarted 2023-10-16
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 …
What they're measuring
1
DNA yield from esophageal cytology samples collected with the Cytosponge device