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

ConditionsBarrett's EsophagusEsophageal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Colorado, Denver

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients with squamous cell carcinoma

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic eradication therapies (EET)

    Procedure/Surgery

    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.

  • Esophagectomy

    Procedure/Surgery

    The esophagus is surgically removed

  • Chemotherapy

    Drug

    Chemical substances are used to treat cancer

  • Radiation

    Radiation

    Cancer cells are destroyed by radiation therapy.

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: Patients with Barrett's Esophagus1 intervention
Group B: Patients with invasive esophageal cancer3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years
2

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

Time frame
5 years
3

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)

Time frame
5 years
4

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).

Time frame
5 years

Other outcomes

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

Northwestern University

Collaborator

University of California, Los Angeles

Collaborator

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

California Pacific Medical Center

Collaborator

Source ClinicalTrials.gov
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