TREAT-BE Study (Treatment with Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
- Conditions
- Barrett's EsophagusEsophageal Cancer
- Interventions
- Procedure: Endoscopic eradication therapies (EET)Procedure: EsophagectomyDrug: ChemotherapyRadiation: Radiation
- Registration Number
- NCT02634645
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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).
- Detailed Description
Patients will be enrolled in this study at the participating centers when evaluated in gastro-intestinal (GI) clinics and endoscopy suites. Initial evaluation of patients will include collection of data on demographics, assessment of risk factors such as smoking, metabolic syndrome, family history and detailed medication history, and past surgical history. All patients will be complete questionnaires regarding Gastroesophageal Reflux Disease (GERD) symptoms, GERD related quality of life (QOL) and overall health related QOL. Details of all previous endoscopic and surgical evaluation along with histopathology data will be documented. Patients undergoing endoscopic evaluation at the participating centers will have their endoscopic and histopathology results documented. This will include data collection regarding use of advanced imaging techniques, details regarding tissue acquisition, EET and adverse events. Patients undergoing esophagectomy will have surgical details documented along with complications related to surgery. Similarly, details regarding chemoradiation treatments will be documented .
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer
- Patients with squamous cell carcinoma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with invasive esophageal cancer Chemotherapy Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities. Patients with invasive esophageal cancer Radiation Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities. Patients with Barrett's Esophagus Endoscopic eradication therapies (EET) Patients 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). Patients with invasive esophageal cancer Esophagectomy Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.
- Primary Outcome Measures
Name Time Method Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). 5 years A systematic, prospective collection of data from a large cohort of patients with BE and EAC undergoing EET will provide useful data in effort to improve overall patient outcomes.
- Secondary Outcome Measures
Name Time Method Median time to recurrence of neoplasia 5 years To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of neoplasia).
Recurrence rate of neoplasia 5 years To report on the recurrence rate of neoplasia (defined as number of patients with established eradicated neoplasia post-EET who are found to have recurrent intestinal metaplasia on subsequent surveillance biopsies)
Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality 5 years Percentage of patients of different baseline Barrett's treatment modalities (EMR vs. RFA vs. cryotherapy) whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's lengths whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's histologies (i.e. high grade dysplasia/intramucosal cancer vs. low grade dysplasia) whose Barrett's is persistent despite treatment and/or recurs post-eradication.
Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia 5 years Number of BE patients (both with and without neoplasia) in the general population who receive various endoscopic interventions (including RFA, cryotherapy, EMR, endoscopic surveillance)
Magnitude of risk factors for BE. 5 years The number of BE patients who fall into specific age cohorts; the number of BE patients who are male/female; the number of BE patients who fall into specific BMI cohorts; the number of BE patients who have used tobacco and/or currently use tobacco; the number of BE patients who have GERD symptoms; the number of BE patients who have metabolic syndrome; the number of BE patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.
Magnitude of risk factors for BE related neoplasia. 5 years The number of BE related neoplasia patients who fall into specific age cohorts; the number of BE related neoplasia patients who are male/female; the number of BE related neoplasia patients who fall into specific BMI cohorts; the number of BE related neoplasia patients who have used tobacco and/or currently use tobacco; the number of BE related neoplasia patients who have GERD symptoms; the number of BE related neoplasia patients who have metabolic syndrome; the number of BE related neoplasia patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.
Magnitude of risk factors for EAC. 5 years The number of EAC patients who fall into specific age cohorts; the number of EAC patients who are male/female; the number of EAC patients who fall into specific BMI cohorts; the number of EAC patients who have used tobacco and/or currently use tobacco; the number of EAC patients who have GERD symptoms; the number of EAC patients who have metabolic syndrome; the number of EAC patients who take aspirin, NSAIDS, anti-hyperglycemic medications, and/or statins.
Long-term effectiveness or durability of EET in BE related neoplasia. 5 years To report on long-term effectiveness or durability of EET in BE related neoplasia.
Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia 5 years To assess quality of life (QOL) using the Promise GERD HRQL (Health Related Quality of Life) questionnaire in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia
Recurrence rate of intestinal metaplasia 5 years To report on the recurrence rate intestinal metaplasia (defined as number of patients with established eradicated intestinal metaplasia and/or neoplasia post-EET who are found to have recurrent intestinal metaplasia on subsequent surveillance biopsies).
Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality 5 years Percentage of patients of different baseline Barrett's treatment modalities (EMR vs. RFA vs. cryotherapy) whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's lengths whose Barrett's is persistent despite treatment and/or recurs post-eradication. Percentage of patients of different baseline Barrett's histologies (i.e. high grade dysplasia/intramucosal cancer vs. low grade dysplasia) whose Barrett's is persistent despite treatment and/or recurs post-eradication.
Adverse event rates associated with EET for BE associated neoplasia and EAC. 5 years To determine adverse event rates associated with EET for BE associated neoplasia and EAC.
Impact of endoscopic and radiologic imaging modalities. 5 years Number of patients whose treatment plan changes due to endoscopic ultrasound and/or Computed Tomography-Positron Emission Tomography (CT-PET) findings
Median time to recurrence of intestinal metaplasia 5 years To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of intestinal metaplasia).
Trial Locations
- Locations (4)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Washington University
🇺🇸St. Louis, Missouri, United States