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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02198976