Recruiting NCT02198976
Australian Barrett's Cohort With Dysplasia and Early Cancer Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Barrett's Esophagus. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to collect prospective observational data regarding endoscopic management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia and/or intramucosal carcinoma. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus
Primary outcome measures
- Number of Serious and Non-Serious Adverse Events [Time frame: During the Barretts Excision]
Secondary outcome measures (1)
- Number of Participants with Serious and Non-Serious Adverse Events [Time frame: Up to 5 years after procedure]
Eligibility criteria
Inclusion criteria
- Can give informed consent to trial participation
- Age greater than 18
- Barrett's oesophagus
Exclusion criteria
- Age less than 18
- Pregnant patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Westmead Endoscopy Unit — Westmead
Identifiers
NCT: NCT02198976 · HREC2013/10/4.1 (3829)