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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Barrett's Esophagus
• Intervention / Treatment: 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 .

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Sachin Wani, MD; Phone Number: 720-848-2786; Email: sachin.wani@ucdenver.edu
• Study Contact Backup: Name: Violette C Simon, MS; Phone Number: 303-724-6670; Email: violette.simon@ucdenver.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Medical Center
      • Contact: V. Raman Muthusamy, MD; Phone Number: 310-825-1892; Email: raman@mednet.ucla.edu
      • Principal Investigator: V. Raman Muthusamy, MD
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Cynthia Harris, MD; Phone Number: 813-745-8361; Email: Cynthia.Harris@moffitt.org
      • Principal Investigator: Cynthia Harris, MD
      • Sub-Investigator: Jason Klapman, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: Srinadh Komanduri, MD; Phone Number: 312-695-0484; Email: koman1973@gmail.com
      • Principal Investigator: Srinadh Komanduri, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University
      • Contact: Dayna Early, MD; Email: dearly@dom.wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with squamous cell carcinoma

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of California, Los Angeles; H. Lee Moffitt Cancer Center and Research Institute; Northwestern University Feinberg School of Medicine; California Pacific Medical Center
• Investigators: Principal Investigator: Sachin Wani, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Wani S, Han S, Kushnir V, Early D, Mullady D, Hammad H, Brauer B, Thaker A, Simon V, Ezekwe E, Hollander T, Wood M, Rastogi A, Edmundowicz S, Muthusamy VR, Komanduri S. Recurrence Is Rare Following Complete Eradication of Intestinal Metaplasia in Patients With Barrett's Esophagus and Peaks at 18 Months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2. doi: 10.1016/j.cgh.2020.01.019. Epub 2020 Jan 23.
• Omar M, Thaker AM, Wani S, Simon V, Ezekwe E, Boniface M, Edmundowicz S, Obuch J, Cinnor B, Brauer BC, Wood M, Early DS, Lang GD, Mullady D, Hollander T, Kushnir V, Komanduri S, Muthusamy VR. Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy. Gastrointest Endosc. 2019 Sep;90(3):395-403. doi: 10.1016/j.gie.2019.04.216. Epub 2019 Apr 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimated): December 18, 2015

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 14-2371