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

NCT ID: NCT02634645

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2027-01-31

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 .

Conditions

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Barrett's Esophagus Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Endoscopic eradication therapies (EET)

Intervention Type PROCEDURE

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.

Esophagectomy

Intervention Type PROCEDURE

The esophagus is surgically removed

Chemotherapy

Intervention Type DRUG

Chemical substances are used to treat cancer

Radiation

Intervention Type RADIATION

Cancer cells are destroyed by radiation therapy.

Interventions

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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.

Intervention Type PROCEDURE

Esophagectomy

The esophagus is surgically removed

Intervention Type PROCEDURE

Chemotherapy

Chemical substances are used to treat cancer

Intervention Type DRUG

Radiation

Cancer cells are destroyed by radiation therapy.

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role collaborator

California Pacific Medical Center

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sachin Wani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sachin Wani, MD

Role: CONTACT

720-848-2786

Violette C Simon, MS

Role: CONTACT

303-724-6670

Facility Contacts

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V. Raman Muthusamy, MD

Role: primary

310-825-1892

Cynthia Harris, MD

Role: primary

813-745-8361

Srinadh Komanduri, MD

Role: primary

312-695-0484

Dayna Early, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31982610 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31004598 (View on PubMed)

Other Identifiers

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14-2371

Identifier Type: -

Identifier Source: org_study_id

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