Barrett's EsophagusABCDENCT02198976
Australian Barrett's Cohort With Dysplasia and Early Cancer Study
An observational study of Barrett's Esophagus, run by Professor Michael Bourke at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2014to Nov 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.
Who may be able to join
- Can give informed consent to trial participation
- Age greater than 18
- Barrett's oesophagus
Who cannot join
- Age less than 18
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Endoscopy Unit
Westmead, New South Wales, 2145
Clarence Kerrison, MBBS, 88905555, clarence.kerrison@health.nsw.gov.au
Michael Bourke, MBBS
About this study
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
- Conditions
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Barrett's Oesophagus | Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious and Non-Serious Adverse Events
Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine
- Long term risk of oesophageal adenocarcinoma (OAC) development
- Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO
- Short and long term safety and complications
- Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.
Measured: During the Barretts Excision
Secondary outcomes (1)
Number of Participants with Serious and Non-Serious Adverse Events
Establish the effect of endoluminal therapies for BO HGD/IMC on oesophageal motility. Document and grade the post EMR oesophageal defect and establish a possible link to subsequent complications (including stricture, bleeding and perforation) and recurrence. Perform cost-utility analyses comparing different treatment approaches for BO HGD/IMC, including EMR, RFA and oesophagectomy. Establish the relationship between Obstructive Sleep Apnea and BO. Understand patient attitudes and perceptions regarding BO, its treatment and its implication.
Participants will be approached following their procedure and data recorded on a datasheet, this data will be linked to the initial procedure outcomes.
Measured: Up to 5 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2034 (estimated)
- Study completionNov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Michael Bourke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael J Bourke, MBBS, Principal investigator, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198976
- Sponsor's protocol ID
- HREC2013/10/4.1 (3829)
- Acronym
- ABCDE
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2014
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australian Barrett's Cohort With Dysplasia and Early Cancer Study
- ClinicalTrials.gov ID
- NCT02198976
- Acronym / sponsor ID
- ABCDE / HREC2013/10/4.1 (3829)
- Conditions
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Professor Michael BourkeUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2034 (estimated)
- Study completion
- Nov 2034 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's Oesophagus | – | –Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.
Key inclusion criteria (3 listed)
- Can give informed consent to trial participation
- Age greater than 18
- Barrett's oesophagus
Key exclusion criteria (2 listed)
- Age less than 18
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Serious and Non-Serious Adverse Events
Time frame: During the Barretts Excision
Collect prospective observational data on patients undergoing endoluminal therapy for dysplastic BO to determine * Long term risk of oesophageal adenocarcinoma (OAC) development * Long term efficacy (dysplasia and metaplasia free) in both long and short segment BO * Short and long term safety and complications * Comparison of the safety, long term efficacy, cost and patient tolerability between endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) Document the endoscopic location and characterise morphology of HGD/IMC in short and long segment BO Define the short term and long term causes of morbidity / mortality of patients undergoing ER This will be recorded on a datasheet, de-identified during the procedure.
1 secondary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 5 years after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Bourke, MBBS principal investigator
Western Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by Professor Michael Bourke at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Bourke, MBBS (88905555, michael@citywestgastro.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious and Non-Serious Adverse Events (time frame: During the Barretts Excision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.