Clinical trial NCT02634645: TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Barrett's Esophagus
Esophageal Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
name: University of California, Los Angeles
name: H. Lee Moffitt Cancer Center and Research Institute
name: California Pacific Medical Center
First posted: 2015-12-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with squamous cell carcinoma

Primary outcomes:
measure: Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET).
timeFrame: 5 years
Secondary outcomes:
measure: Long-term effectiveness or durability of EET in BE related neoplasia.
timeFrame: 5 years
measure: Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia
timeFrame: 5 years
measure: Recurrence rate of neoplasia
timeFrame: 5 years
measure: Recurrence rate of intestinal metaplasia
timeFrame: 5 years
measure: Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality
timeFrame: 5 years
measure: Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality
timeFrame: 5 years
measure: Adverse event rates associated with EET for BE associated neoplasia and EAC.
timeFrame: 5 years
measure: Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia
timeFrame: 5 years
measure: Magnitude of risk factors for BE.
timeFrame: 5 years
measure: Magnitude of risk factors for BE related neoplasia.
timeFrame: 5 years
measure: Magnitude of risk factors for EAC.
timeFrame: 5 years
measure: Impact of endoscopic and radiologic imaging modalities.
timeFrame: 5 years
measure: Median time to recurrence of intestinal metaplasia
timeFrame: 5 years
measure: Median time to recurrence of neoplasia
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: University of Colorado, Denver
name: Sachin Wani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.