Barrett's Esophagus Patient Registry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01776346

Acronym

BPR

Enrollment

750

Registered

2013-01-28

Start date

2011-01-31

Completion date

2021-12-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Esophageal Adenocarcinoma, Gastroesophageal Reflux

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Progression to esophageal adenocarcinoma	5 years (on average although follow-up will continue)

Secondary

Measure	Time frame
Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy	5 years on average
Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases	5 years on average

Countries

United States

Contacts

Primary ContactKatherine Perzan, BA

kperzan@partners.org617-726-1431

Outcome results