Barrett's EsophagusBetrnetRFNCT01568723
Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation
An observational study of Barrett's Esophagus, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- response to therapy
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to 16 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must have biopsy proven Barret's esophgus with evidence of specialized intestinal epithelium with high grade dysplasia or early intramucosal carcinoma (mEAC) on histology (confirmed by two pathologists). Patients must have a BE length ≥ 2 cm and ≤ 8 cm.
Who may be able to join
- Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
- BE length ≥ 2 cm and ≤ 8 cm.
- Able to return every 3 months for one year after ablation
Who cannot join
- Patients who are unable to be compliant with follow-up endoscopies
- patients who cannot tolerate Proton Pump inhibitors
- pre-existing esophageal strictures
- pregnant or nursing women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104-4311
About this study
Official title: Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
Read the detailed description
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.
- Conditions
- Barrett's Esophagus
- Being tested
- response to therapy
- Keywords
- Barrett's esophagus, high grade dysplasia, ablation, radiofrequency ablation, esophageal cancer
- 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.
response to therapyGenetic
evaluate specific markers for response to therapy at specific intervals pre and post therapy
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA) Receives: Genetic: response to therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to therapy
evaulation will be made at 3 month intervals for one year post ablation
Measured: one year post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2012
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kenneth K. Wang, Mayo Clinic
- Investigators
- Kenneth K Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568723
- Sponsor's protocol ID
- 11-006510
- Other IDs
- U54CA163004
- Acronym
- BetrnetRF
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2012
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT01568723
- Acronym / sponsor ID
- BetrnetRF / 11-006510
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's esophagus, high grade dysplasia, ablation, radiofrequency ablation, esophageal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 2 Apr 2012 (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.
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
Detailed description
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | – | Genetic: response to therapyparticipants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must have biopsy proven Barret's esophgus with evidence of specialized intestinal epithelium with high grade dysplasia or early intramucosal carcinoma (mEAC) on histology (confirmed by two pathologists). Patients must have a BE length ≥ 2 cm and ≤ 8 cm.
Key inclusion criteria (3 listed)
- Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
- BE length ≥ 2 cm and ≤ 8 cm.
- Able to return every 3 months for one year after ablation
Key exclusion criteria (4 listed)
- Patients who are unable to be compliant with follow-up endoscopies
- patients who cannot tolerate Proton Pump inhibitors
- pre-existing esophageal strictures
- pregnant or nursing women
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 |
|---|---|---|
| response to therapyevaluate specific markers for response to therapy at specific intervals pre and post therapy | Genetic | Radiofrequency ablation |
Primary outcome
Response to therapy
Time frame: one year post ablation
evaulation will be made at 3 month intervals for one year post ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Barrett's Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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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. This study is not recruiting at the moment.
Kenneth K Wang, MD principal investigator
Mayo Clinic
2 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, run by Mayo Clinic at 2 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to therapy (time frame: one year post ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2021.