Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
NCT ID: NCT03961945
Last Updated: 2025-08-27
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
1550 participants
INTERVENTIONAL
2021-07-01
2027-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Screening Population
Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.
Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Upper endoscopy - Barrett's Esophagus
Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Upper endoscopy - No Barrett's Esophagus
Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Interventions
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Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have three or more risk factors for Barrett's Esophagus.
* Gastroesophageal reflux disease defined by:
* Diagnosis
* Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
* prior endoscopic diagnosis of erosive esophagitis
* Body mass index (BMI) \>= 30
* Subjects with known or suspected BE (cases).
* Patient between the ages 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
* esophageal adenocarcinoma/cancer
* esophageal squamous carcinoma
* endoscopic ablation for Barrett's esophagus
* esophageal squamous dysplasia
* Current treatment with oral anticoagulation including Warfarin, Coumadin
* History of cirrhosis
* History of esophageal/gastric varices
* History of Barrett's esophagus
* Prior endoscopy in the last 5 years
* Subjects with known BE.
* Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.
* Patients with history of esophageal resection for esophageal carcinoma.
* 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 (this does not apply to the brushings/biopsies only portion of the study).
* History of eosinophilic esophagitis, achalasia.
* Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
* Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge 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 sponge 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
Yes
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, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Health Systems - Austin
Austin, Minnesota, United States
Mayo Clinic Health Systems - Mankato
Mankato, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Northwell Health
New Hyde Park, New York, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-14395
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-002629
Identifier Type: -
Identifier Source: org_study_id
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