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

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ClinicalTrials.gov Identifier: NCT02634645
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
Feinberg School of Medicine, Northwestern University
University of California, Los Angeles
H. Lee Moffitt Cancer Center and Research Institute
California Pacific Medical Center
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Barrett's Esophagus Esophageal Cancer Procedure: Endoscopic eradication therapies (EET) Procedure: Esophagectomy Drug: Chemotherapy Radiation: Radiation

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 .

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2015
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with Barrett's Esophagus
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)
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.

Patients with invasive esophageal cancer
Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities.
Procedure: Esophagectomy
The esophagus is surgically removed

Drug: Chemotherapy
Chemical substances are used to treat cancer

Radiation: Radiation
Cancer cells are destroyed by radiation therapy.




Primary Outcome Measures :
  1. Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). [ Time Frame: 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 :
  1. Long-term effectiveness or durability of EET in BE related neoplasia. [ Time Frame: 5 years ]
    To report on long-term effectiveness or durability of EET in BE related neoplasia.

  2. Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia [ Time Frame: 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

  3. Recurrence rate of neoplasia [ Time Frame: 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)

  4. Recurrence rate of intestinal metaplasia [ Time Frame: 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).

  5. Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality [ Time Frame: 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.

  6. Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality [ Time Frame: 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.

  7. Adverse event rates associated with EET for BE associated neoplasia and EAC. [ Time Frame: 5 years ]
    To determine adverse event rates associated with EET for BE associated neoplasia and EAC.

  8. Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia [ Time Frame: 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)

  9. Magnitude of risk factors for BE. [ Time Frame: 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.

  10. Magnitude of risk factors for BE related neoplasia. [ Time Frame: 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.

  11. Magnitude of risk factors for EAC. [ Time Frame: 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.

  12. Impact of endoscopic and radiologic imaging modalities. [ Time Frame: 5 years ]
    Number of patients whose treatment plan changes due to endoscopic ultrasound and/or Computed Tomography-Positron Emission Tomography (CT-PET) findings

  13. Median time to recurrence of intestinal metaplasia [ Time Frame: 5 years ]
    To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of intestinal metaplasia).

  14. Median time to recurrence of neoplasia [ Time Frame: 5 years ]
    To report on the median time to recurrence (measured median amount of months between complete eradication and recurrence of neoplasia).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Formation of a multi-site prospective database of patients with BE associated neoplasia referred for consideration for EET and EAC.

Women and minorities will be included as they are found to have BE, BE related dysplasia, and EAC. It is well recognized that the majority of patients diagnosed with BE are white males. However, we will actively seek to include all women and minorities with a diagnosis of BE associated neoplasia for the study.

Criteria

Inclusion Criteria:

  • Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer

Exclusion Criteria:

  • Patients with squamous cell carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634645


Contacts
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Contact: Sachin Wani, MD 720-848-2786 sachin.wani@ucdenver.edu
Contact: Violette C Simon, MS 303-724-6670 violette.simon@ucdenver.edu

Locations
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United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: V. Raman Muthusamy, MD    310-825-1892    raman@mednet.ucla.edu   
Principal Investigator: V. Raman Muthusamy, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Cynthia Harris, MD    813-745-8361    Cynthia.Harris@moffitt.org   
Principal Investigator: Cynthia Harris, MD         
Sub-Investigator: Jason Klapman, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Srinadh Komanduri, MD    312-695-0484    koman1973@gmail.com   
Principal Investigator: Srinadh Komanduri, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Dayna Early, MD       dearly@dom.wustl.edu   
Sponsors and Collaborators
University of Colorado, Denver
Feinberg School of Medicine, Northwestern University
University of California, Los Angeles
H. Lee Moffitt Cancer Center and Research Institute
California Pacific Medical Center
Investigators
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Principal Investigator: Sachin Wani, MD University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02634645    
Other Study ID Numbers: 14-2371
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Barrett Esophagus
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Precancerous Conditions