Barrett EsophagusBPRNCT01776346
Barrett's Esophagus Patient Registry
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma, Gastroesophageal Reflux
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2021
- How long will I take part?
- 5 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been seen at Massachusetts General Hospital.
Who may be able to join
- Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
- Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
- The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.
Who cannot join
- Inability or unwillingness to provide blood samples.
- History of known bleeding disorders.
- Currently awaiting organ transplantation.
- Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Katherine Perzan, BA, 617-726-1431, kperzan@partners.org
About this study
The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Barrett's Esophagus/Esophageal Adenocarcinoma | Patients who have Barrett's esophagus or esophageal adenocarcinoma. | |
| Healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to esophageal adenocarcinoma
Measured: 5 years (on average although follow-up will continue)
Secondary outcomes (2)
Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy
Measured: 5 years on average
Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases
Measured: 5 years on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Hur, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776346
- Sponsor's protocol ID
- 2010P002224
- Acronym
- BPR
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrett's Esophagus Patient Registry
- ClinicalTrials.gov ID
- NCT01776346
- Acronym / sponsor ID
- BPR / 2010P002224
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Jan 2013 (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 ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barrett's Esophagus/Esophageal Adenocarcinoma | – | –Patients who have Barrett's esophagus or esophageal adenocarcinoma. |
| Healthy control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been seen at Massachusetts General Hospital.
Key inclusion criteria (3 listed)
- Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
- Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
- The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.
Key exclusion criteria (4 listed)
- Inability or unwillingness to provide blood samples.
- History of known bleeding disorders.
- Currently awaiting organ transplantation.
- Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression to esophageal adenocarcinoma
Time frame: 5 years (on average although follow-up will continue)
2 secondary outcomes
Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy
Time frame: 5 years on average
Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases
Time frame: 5 years on average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Massachusetts General Hospital at 1 site 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: status not confirmed, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Perzan, BA (617-726-1431, kperzan@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to esophageal adenocarcinoma (time frame: 5 years (on average although follow-up will continue)). 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 28 Jan 2013.