TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT02634645
- Status
- Recruiting
Conditions
- Barrett's Esophagus
- Esophageal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Accepted
Interventions
- Endoscopic eradication therapies (EET) — PROCEDUREEndoscopic eradication therapies (EET) includes endoscopic mucosal resection (EMR), which describes the process by which the area most likely to harbor highest grade of dysplasia/neoplasia is removed; radiofrequency ablation (RFA), which describes the process by which Barrett's segments are removed via burning/ablation; and cryotherapy.
- Esophagectomy — PROCEDUREThe esophagus is surgically removed
- Chemotherapy — DRUGChemical substances are used to treat cancer
- Radiation — RADIATIONCancer cells are destroyed by radiation therapy.
Study Details
A prospective outcomes study in patients with and esophageal cancer (EAC) and Barrett's esophagus (BE) associated neoplasia being evaluated for endoscopic eradication therapy (EET).
Key Dates
- Start date
- Jan 31, 2015
- Status verified
- Feb 2025
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Patients with Barrett's EsophagusPatients with non-dysplastic Barrett's esophagus, patients with Barrett's related dysplasia which includes low-grade dysplasia, high-grade dysplasia and intramucosal cancer who will be evaluated and treated with endoscopic eradication therapies (EET).
- Arm: Patients with invasive esophageal cancerPatients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.
Primary Outcome Measure
Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). [ Time Frame: 5 years ]
Central Contacts
- Sachin Wani, MD720-848-2786
- Violette C Simon, MS303-724-6670
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | V. Raman Muthusamy, MD (PRINCIPAL_INVESTIGATOR) |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Cynthia Harris, MD (PRINCIPAL_INVESTIGATOR) Jason Klapman, MD (SUB_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Srinadh Komanduri, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University | St Louis | Missouri | 63130 | Dayna Early, MD |
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