Actively Recruiting
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
Led by Mayo Clinic · Updated on 2026-06-02
450
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Cytosponge, a minimally invasive device for collecting esophageal cells, to detect Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in patients undergoing endoscopy. This approach combines the Cytosponge with the Oncoguard Esophagus test (OGE test), which identifies biomarkers indicating the presence of BE or EAC. The study aims to assess DNA yield from samples collected with the Cytosponge and the accuracy of the OGE test in detecting methylated DNA markers. Additionally, the study evaluates the tolerability and safety of the Cytosponge device. Participants are assigned to one of two groups: those with known or suspected BE and those without known BE. Both groups undergo the Cytosponge procedure followed by a clinically indicated sedated endoscopy using standard equipment. The Cytosponge device is administered and retrieved according to instructions, then placed in a preservative solution and sent for laboratory analysis. Participants complete surveys during the study to report tolerability and any symptoms. During the study, researchers measure DNA yield and the accuracy of the OGE test over 12 months. They also assess the tolerability of the Cytosponge device and check for any esophageal trauma within 7 days using questionnaires and endoscopic injury scores. The study includes standard endoscopic evaluations and collects participant feedback to understand the experience. The total participation period covers these assessments and follow-ups as scheduled.
CONDITIONS
Brief Title
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 90 years
- Subjects with known or suspected Barrett's esophagus (BE) with a BE segment of 1 cm or more or suspected BE in medical records
- Histology showing intestinal metaplasia with or without dysplasia or suspected BE in medical records
- Undergoing clinically indicated endoscopy
- Subjects without known history of BE undergoing clinically indicated diagnostic endoscopy
You will not qualify if you...
- Pregnant or lactating females
- Patients unable to consent
- Current history of uninvestigated dysphagia
- History of eosinophilic esophagitis or achalasia
- Use of oral anticoagulants such as Coumadin or Warfarin
- Use of antiplatelet agents including Clopidogrel unless stopped 3-5 days before Cytosponge procedure
- Use of oral thrombin inhibitors like Dabigatran or factor Xa inhibitors such as rivaroxaban, apixaban, edoxaban unless stopped 3-5 days before Cytosponge procedure
- History of esophageal or gastric varices or cirrhosis
- History of surgical esophageal resection for esophageal carcinoma
- Congenital or acquired bleeding disorders
- History of esophageal squamous dysplasia
- Known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, duodenum) within 5 years prior to enrollment
- Prior chemotherapy or radiation treatment for mediastinal or esophageal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo sample collection with the Cytosponge device and a diagnostic sedated endoscopy to evaluate the presence of Barrett's Esophagus or related conditions.
1 visit for Cytosponge procedure and endoscopy
Duration - 7 days
Participants complete surveys and assessments including tolerability of the Cytosponge device and evaluation of esophageal trauma following the procedures.
1 to 2 follow-up visits
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Terminated
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, United States, 11040
Completed
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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