NCT02198976|RecruitingDMC
Australian Barrett's Cohort With Dysplasia and Early Cancer Study
ABCDE
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ABCDE
Sponsor study identifier
observational
300
1 country
1
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2014
Actual (reported)July 24, 2014
Actual (reported)May 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
During the Barretts Excision
Number of Participants with Serious and Non-Serious Adverse Events
Up to 5 years after procedure
Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)
Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.
Westmead Endoscopy Unit
Westmead, New South Wales, 2145, Australia
Michael J Bourke, MBBS
Western Sydney Local Health District
First Submitted
July 17, 2014
First Posted
July 24, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2034
Cryo Balloon for Residual Barrett's Esophagus
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 27, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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