NCT00590239 Barrett's Esophagus Related Neoplasia (BERN) Project
| NCT ID | NCT00590239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Midwest Biomedical Research Foundation |
| Condition | Barrett's Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2007-05-15 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2007-05-15 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early neoplasia. * Endoscopic mucosal resection (EMR) will improve the accuracy for detection of dysplasia/early neoplasia. Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies. Specific Aim 2 - To create a standardized classification system for the mucosal and vascular patterns observed in patients with BE. Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the mucosal and vascular patterns classification agreed upon. Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or precancerous lesions removed during endoscopy. Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing EMR/ablation; including morbidity, mortality and complications of the procedure. Results to date (June 2008) : this study is active and open to enrollment. Currently 26 patients have enrolled in this study at the Kansas City VA medical center. In order to participate, patients must be eligible for care at the KCVA hospital.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Prateek Sharma, MD
PRINCIPAL INVESTIGATOR
Kansas City VA Medical Center
Frequently Asked Questions
Who can join the NCT00590239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett's Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00590239 currently recruiting?
Yes, NCT00590239 is actively recruiting participants. Contact the research team at April.Higbee@va.gov for enrollment information.
Where is the NCT00590239 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT00590239 clinical trial?
NCT00590239 is sponsored by Midwest Biomedical Research Foundation. The principal investigator is Prateek Sharma, MD at Kansas City VA Medical Center. The trial plans to enroll 150 participants.