Status:
RECRUITING
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Lead Sponsor:
Mayo Clinic
Conditions:
Barrett Esophagus
Barretts Esophagus With Dysplasia
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device. II. Evaluate the methylated DNA markers (MDM) levels and accur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06071845
Start Date
October 16 2023
End Date
June 1 2026
Last Update
December 16 2025
Active Locations (5)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905