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Trial Title:
Barrett's Esophagus Patient Registry
NCT ID:
NCT01776346
Condition:
Barrett Esophagus
Esophageal Adenocarcinoma
Gastroesophageal Reflux
Conditions: Official terms:
Barrett Esophagus
Gastroesophageal Reflux
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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. 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.
Criteria for eligibility:
Study pop:
Patients who have been seen at Massachusetts General Hospital.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Perzan, BA
Phone:
617-726-1431
Email:
kperzan@partners.org
Start date:
January 2011
Completion date:
December 2021
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01776346
