Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02198976




Registration number
NCT02198976
Ethics application status
Date submitted
17/07/2014
Date registered
24/07/2014
Date last updated
24/07/2024

Titles & IDs
Public title
Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Scientific title
Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Secondary ID [1] 0 0
HREC2013/10/4.1 (3829)
Universal Trial Number (UTN)
Trial acronym
ABCDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett's Esophagus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Barrett's Oesophagus - Patients with Barrett's Oesophagus with either high grade dysplasia (HGD) or intramucosal cancer (IMC)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Serious and Non-Serious Adverse Events
Timepoint [1] 0 0
During the Barretts Excision
Secondary outcome [1] 0 0
Number of Participants with Serious and Non-Serious Adverse Events
Timepoint [1] 0 0
Up to 5 years after procedure

Eligibility
Key inclusion criteria
* Can give informed consent to trial participation
* Age greater than 18
* Barrett's oesophagus
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age less than 18
* Pregnant patients

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2034
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus
Trial website
https://clinicaltrials.gov/study/NCT02198976
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathleen Goodrick, BN
Address 0 0
Country 0 0
Phone 0 0
98455555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02198976