TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)

Study Overview
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Brief Summary
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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
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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 .

Official Title
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A Multicenter Prospective Study Evaluating Outcomes of Endoscopic Eradication Therapy in Patients With Barrett's Esophagus Associated Neoplasia: The TREAT-BE (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus) Consortium

Conditions
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Barrett's Esophagus, Esophageal Cancer

Intervention / Treatment
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* Procedure: Endoscopic eradication therapies (EET)
* Procedure: Esophagectomy
* Drug: Chemotherapy
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer Exclusion Criteria: Patients with squamous cell carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Barrett's Esophagus<br>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). | Procedure: Endoscopic eradication therapies (EET)<br>* Endoscopic 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.<br>|
| Patients with invasive esophageal cancer<br>Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities. | Procedure: Esophagectomy<br>* The esophagus is surgically removed<br>Drug: Chemotherapy<br>* Chemical substances are used to treat cancer<br>Radiation: Radiation<br>* Cancer cells are destroyed by radiation therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effectiveness or durability of EET in BE related neoplasia. | To report on long-term effectiveness or durability of EET in BE related neoplasia. | 5 years | 
| Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia | 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 | 5 years | 
| Recurrence rate of neoplasia | 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) | 5 years | 
| Recurrence rate of intestinal metaplasia | 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). | 5 years | 
| Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality | 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. | 5 years | 
| Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality | 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. | 5 years | 
| Adverse event rates associated with EET for BE associated neoplasia and EAC. | To determine adverse event rates associated with EET for BE associated neoplasia and EAC. | 5 years | 
| Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia | Number of BE patients (both with and without neoplasia) in the general population who receive various endoscopic interventions (including RFA, cryotherapy, EMR, endoscopic surveillance) | 5 years | 
| Magnitude of risk factors for BE. | 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. | 5 years | 
| Magnitude of risk factors for BE related neoplasia. | 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. | 5 years | 
| Magnitude of risk factors for EAC. | 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. | 5 years | 
| Impact of endoscopic and radiologic imaging modalities. | Number of patients whose treatment plan changes due to endoscopic ultrasound and/or Computed Tomography-Positron Emission Tomography (CT-PET) findings | 5 years | 
| Median time to recurrence of intestinal metaplasia | To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of intestinal metaplasia). | 5 years | 
| Median time to recurrence of neoplasia | To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of neoplasia). | 5 years |