Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
NCT ID: NCT06071845
Last Updated: 2025-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-10-16
2026-06-01
Brief Summary
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Detailed Description
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I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device.
II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples.
SECONDARY OBJECTIVES:
I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Known or Suspected Barrett's Esophagus (Case Arm)
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
Cytosponge Procedure
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic Assessment
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
No Known Barrett's Esophagus (Control Arm)
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Cytosponge Procedure
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic Assessment
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Interventions
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Cytosponge Procedure
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic Assessment
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Prasad G. Iyer, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Molly Stewart
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-07131
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-010506
Identifier Type: -
Identifier Source: org_study_id