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 States450 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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DNA yield from esophageal cytology samples collected with the Cytosponge device