Actively Recruiting

Age: 18Years - 99Years
All Genders
ID02198976

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Led by Professor Michael Bourke · Updated on 2025-03-27

300

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting observational data to understand the management and outcomes for patients with Barrett's oesophagus who have high grade dysplasia or early intramucosal carcinoma. This study also follows patients with low grade dysplastic and non-dysplastic Barrett's oesophagus to observe the natural progression of the condition over time. The focus is on gathering real-world information about these patients to improve knowledge about their disease course and treatment effects. This is an observational study without experimental treatments. It includes patients diagnosed with Barrett's oesophagus who have either high grade dysplasia or early cancer changes in the oesophagus. Participants are monitored during their usual care and Barrett's excision procedures, with no assigned interventions or randomization. The study observes outcomes and any adverse events that occur during and up to five years after these procedures. Participants undergo regular monitoring to track any serious or non-serious adverse events related to their Barrett's oesophagus treatment. Data collection includes clinical assessments and follow-up visits as part of routine care. The primary outcome measured is the number of adverse events during Barrett's excision, with secondary outcomes capturing adverse events up to five years post-procedure. This long-term observation helps researchers understand the safety and natural history of Barrett's oesophagus management over a decade-long timeframe.

CONDITIONS

Brief Title

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Can give informed consent to trial participation
  • Age greater than 18
  • Barrett's oesophagus
Not Eligible

You will not qualify if you...

  • Age less than 18
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants with Barrett's Oesophagus are observed to monitor their condition, including any adverse events during and after excision procedures.

Regular visits depending on clinical needs

Trial Site Locations

Total: 1 location

1

Westmead Endoscopy Unit

Westmead, New South Wales, Australia, 2145

Actively Recruiting

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Research Team

M

Michael Bourke, MBBS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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