Barrett's EsophagusNCT02634645
TREAT-BE Study (Treatment With Resection and Endoscopic Ablation Techniques for Barrett's Esophagus)
An observational study of Barrett's Esophagus and Esophageal Cancer, run by University of Colorado, Denver at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus, Esophageal Cancer
- What is being tested?
- Endoscopic eradication therapies (EET), Esophagectomy and Chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2015to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer
Who cannot join
- Patients with squamous cell carcinoma
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Srinadh Komanduri, MD, 312-695-0484, koman1973@gmail.com
Srinadh Komanduri, MD
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
V. Raman Muthusamy, MD, 310-825-1892, raman@mednet.ucla.edu
V. Raman Muthusamy, MD
- Recruiting
Washington University
St Louis, Missouri, 63130
Dayna Early, MD, dearly@dom.wustl.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Cynthia Harris, MD, 813-745-8361, Cynthia.Harris@moffitt.org
Cynthia Harris, MD
About this study
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
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).
Read the 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 .
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Being tested
- Endoscopic eradication therapies (EET), Esophagectomy, Chemotherapy, Radiation
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic eradication therapies (EET)Procedure or 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.
EsophagectomyProcedure or surgery
The esophagus is surgically removed
ChemotherapyDrug
Chemical substances are used to treat cancer
RadiationRadiation
Cancer cells are destroyed by radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Endoscopic eradication therapies (EET) | |
| Patients with invasive esophageal cancer | Patients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities. Receives: Procedure: Esophagectomy; Drug: Chemotherapy; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (14)
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.
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, H. Lee Moffitt Cancer Center and Research Institute, California Pacific Medical Center
- Responsible party
- Sponsor
- Investigators
- Sachin Wani, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634645
- Sponsor's protocol ID
- 14-2371
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2015
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Enke T, Pokala SK, Hensen C, Brennan C, Gallegos J, Hochheimer CJ, Muthusamy VR, Thaker AM, Kushnir V, Early D, Rastogi A, Hammad H, Edmundowicz SA, Komanduri S, Wani S. Recurrent Barrett's esophagus-related neoplasia is uncommon after successful endoscopic eradication therapy over long-term follow-up. Dis Esophagus. 2026 Jan 9;39(1):doag018. doi: 10.1093/dote/doag018.
PubMed 41758692Wani 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.
PubMed 31982610Omar 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.
PubMed 31004598
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02634645
- Acronym / sponsor ID
- 14-2371
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, H. Lee Moffitt Cancer Center and Research Institute, California Pacific Medical Center
- Study start
- Jan 2015
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Barrett's Esophagus | – | Procedure: Endoscopic eradication therapies (EET)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). |
| Patients with invasive esophageal cancer | – | Procedure: Esophagectomy, Drug: Chemotherapy, Radiation: RadiationPatients with invasive esophageal cancer who will be treated with surgery (esophagectomy), chemotherapy, radiation, and palliative treatment modalities. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with Barrett's related neoplasia and dysplasia. Patients with esophageal cancer
Key exclusion criteria (1 listed)
- Patients with squamous cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients with Barrett's Esophagus |
| EsophagectomyThe esophagus is surgically removed | Procedure or surgery | Patients with invasive esophageal cancer |
| ChemotherapyChemical substances are used to treat cancer | Drug | Patients with invasive esophageal cancer |
| RadiationCancer cells are destroyed by radiation therapy. | Radiation | Patients with invasive esophageal cancer |
Primary outcome
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.
14 secondary outcomes
Long-term effectiveness or durability of EET in BE related neoplasia.
Time frame: 5 years
Quality of life (QOL) in patients undergoing endoscopic eradication therapies for Barrett's associated neoplasia
Time frame: 5 years
Recurrence rate of neoplasia
Time frame: 5 years
Recurrence rate of intestinal metaplasia
Time frame: 5 years
Recurrence rate based on baseline dysplasia, Barrett's length, and treatment modality
Time frame: 5 years
Persistence rate based on baseline dysplasia, Barrett's length, and treatment modality
Time frame: 5 years
Adverse event rates associated with EET for BE associated neoplasia and EAC.
Time frame: 5 years
Determine health-care utilization including endoscopic surveillance practices and outcomes in BE patients with and without neoplasia
Time frame: 5 years
Magnitude of risk factors for BE.
Time frame: 5 years
Magnitude of risk factors for BE related neoplasia.
Time frame: 5 years
Magnitude of risk factors for EAC.
Time frame: 5 years
Impact of endoscopic and radiologic imaging modalities.
Time frame: 5 years
Median time to recurrence of intestinal metaplasia
Time frame: 5 years
Median time to recurrence of neoplasia
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 41758692Enke T, Pokala SK, Hensen C, Brennan C, Gallegos J, Hochheimer CJ, Muthusamy VR, Thaker AM, Kushnir V, Early D, Rastogi A, Hammad H, Edmundowicz SA, Komanduri S, Wani S. Recurrent Barrett's esophagus-related neoplasia is uncommon after successful endoscopic eradication therapy over long-term follow-up. Dis Esophagus. 2026 Jan 9;39(1):doag018. doi: 10.1093/dote/doag018.
- Derived from this study: PubMed 31982610Wani 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.
- Derived from this study: PubMed 31004598Omar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sachin Wani, MD principal investigator
University of Colorado, Denver
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Esophageal Cancer, run by University of Colorado, Denver at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sachin Wani, MD (720-848-2786, sachin.wani@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall improvement of patient outcomes in patients treated with endoscopic eradication therapy (EET). (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634645, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.