Barrett's Esophagus Related Neoplasia (BERN) Project

This study, called the BERN Project, is looking at better ways to find early signs of cancer in people with Barrett's Esophagus (a condition where the lining of the esophagus changes due to acid reflux). Researchers are using special endoscopy techniques (looking inside the body with a camera) like high-resolution endoscopy, narrow band imaging, and chromoendoscopy to create a video-atlas of these changes. This atlas will help train doctors and create a standard way to classify what they see. The study also aims to see how well doctors agree on these classifications. You can join if you are 18-80 years old, can give written permission, and are having an endoscopy for screening or treatment of Barrett's Esophagus. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 150 participants. It is not testing a specific drug or intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will collect data on video-atlas creation and patient outcomes from 2007 to 2016.

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NCT00590239

Barrett's Esophagus Related Neoplasia (BERN) Project

Recruiting
Not specifiedAges 18+Observational
Midwest Biomedical Research
~150 participants
Updated 2024-11-22 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Video-atlas creation
Measured over March 2007 - June 2016
+1 more outcome measured
Barrett's Esophagus
Neoplasms
Gastroesophageal Reflux
1 sites across 1 states
Missouri1
  • Prateek Sharma, MD · PRINCIPAL_INVESTIGATOR · Kansas City VA Medical Center

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Eligibility criteria

Inclusion

18-80 years
Patients must be able to provide written informed consent
Patients referred for endoscopy for screening/surveillance of BE or for endoscopic treatment of BE with early mucosal neoplasia

Exclusion

Current use of aspirin, non-steroidal anti-inflammatory agents(NSAIDs),or chronic anticoagulants that cannot be discontinued prior to the procedure.
Inability to provide written informed consent
Significant thrombocytopenia or coagulopathy
Any significant co-morbid condition that would prevent the safe administration of conscious sedation
  • Video-atlas creationMarch 2007 - June 2016

    To create a video-atlas of early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies.

  • Pathologic and Clinical Outcomes2007 - 2016

    To determine the pathologic and clinical outcomes of patients undergoing EMR / ablation; including morbidity, mortality and complications of the procedure.