Clinical trial · Observational
Barrett's Esophagus Patient Registry
NCT01776346CI-TRIAL-00009171BPRunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Barrett's Esophagus/Esophageal Adenocarcinoma
- description
- Patients who have Barrett's esophagus or esophageal adenocarcinoma.
- label
- Healthy control
Primary outcomes (1)
- measure
- Progression to esophageal adenocarcinoma
- timeFrame
- 5 years (on average although follow-up will continue)
Secondary outcomes (2)
- measure
- Identify and validate genetic determinants that predict progression of BE to EAC and predict response to BE therapy
- timeFrame
- 5 years on average
- measure
- Evaluate the natural history of BE with and without treatment based on clinical, functional and economic outcomes of the cases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.