NCT06071845 Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
| NCT ID | NCT06071845 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Barrett Esophagus |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2023-10-16 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Prasad G. Iyer, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06071845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06071845 currently recruiting?
Yes, NCT06071845 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06071845 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Chicago, United States, Rochester, United States and 1 additional location.
Who is sponsoring the NCT06071845 clinical trial?
NCT06071845 is sponsored by Mayo Clinic. The principal investigator is Prasad G. Iyer, MD at Mayo Clinic in Rochester. The trial plans to enroll 450 participants.