Barrett's Esophagus Patient Registry (BPR)
This study is currently recruiting participants.
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Chin Hur, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01776346
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition |
|---|
|
Barrett Esophagus Esophageal Adenocarcinoma Gastroesophageal Reflux |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Barrett's Esophagus Patient Registry |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Progression to esophageal adenocarcinoma [ Time Frame: 5 years (on average although follow-up will continue) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy [ Time Frame: 5 years on average ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum (from whole blood), plasma (from whole blood), tissue
| Estimated Enrollment: | 750 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2021 |
| Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Barrett's Esophagus/Esophageal Adenocarcinoma
Patients who have Barrett's esophagus or esophageal adenocarcinoma.
|
| Healthy control |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who have been seen at Massachusetts General Hospital.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776346
Contacts
| Contact: Katherine Perzan, BA | 617-726-1431 | kperzan@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Katherine Perzan, BA 617-726-1431 kperzan@partners.org | |
Sponsors and Collaborators
Massachusetts General Hospital
More Information
No publications provided
| Responsible Party: | Chin Hur, Principal Investigator; MD, MPH, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01776346 History of Changes |
| Other Study ID Numbers: | 2010P002224 |
| Study First Received: | January 22, 2013 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Barrett Esophagus Esophageal Diseases Gastroesophageal Reflux Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Esophageal Motility Disorders Deglutition Disorders |
ClinicalTrials.gov processed this record on May 23, 2013