Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
NCT ID: NCT07212491
Last Updated: 2025-12-31
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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ENROLLING_BY_INVITATION
300 participants
OBSERVATIONAL
2025-11-17
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Observational
Patients undergo capsule sponge assessment over 5-10 minutes prior to standard of care endoscopy. Patients also undergo biopsy and esophageal brushing sample collection and complete questionnaires on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a BE segment \>= 1cm in maximal extent endoscopically
* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
* Undergoing clinically indicated endoscopy
Exclusion Criteria
* Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
* 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 a current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study)
* History of eosinophilic esophagitis, achalasia
* Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for five days prior to the sponge procedure
* Patients on antiplatelet agents including clopidogrel, unless discontinued for five days prior to the sponge procedure
* Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure
* Patients with a history of known varices or cirrhosis
* Patients with a history of esophageal or gastric resection
* Patients with congenital or acquired bleeding diatheses
* Patients with a history of esophageal squamous dysplasia
18 Years
90 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Prasad G. Iyer, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-06712
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-000761
Identifier Type: OTHER
Identifier Source: secondary_id
SOS6C
Identifier Type: OTHER
Identifier Source: secondary_id
SOS6C
Identifier Type: -
Identifier Source: org_study_id