Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000925943
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
17/09/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
GATOR: Development of a detailed database for collection of clinical data in patients with newly diagnosed GAstro-oesophageal Cancer
Scientific title
GATOR: Development of a detailed database for collection of clinical data in patients with newly diagnosed GAstro-oesophageal Cancer
Secondary ID [1] 301022 0
None
Universal Trial Number (UTN)
Trial acronym
GATOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal cancer 317064 0
Condition category
Condition code
Cancer 315229 315229 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
The GATOR study aims to determine characteristics and clinical outcomes of patients with
newly diagnosed gastro-oesophageal cancer in routine clinical practice, and the clinical decision making process involved with treatment selection and timing over a period of 10 years. Patient demographics, clinical and pathological disease factors and treatments will be captured by accessing patient medical records. Clinical details will be captured every 3 - 6 months from diagnosis until the patient's death, with no additional testing required by patients.
Intervention code [1] 317334 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323483 0
Clinical data collection of 500 gastro-oesophageal cancer patients to determine real world clinical outcomes and tumour characteristics in routine clinical practice. This exploratory outcome is being assessed by entry into medical records.
Timepoint [1] 323483 0
3-6 monthly for 10 years
Primary outcome [2] 324637 0
Treatment description of patients with gastro-oesophageal cancer in Australia. This data will be collected through data-linkage to medical records.
Timepoint [2] 324637 0
3-6 monthly for 10 years
Secondary outcome [1] 382035 0
Collection of patient outcome data in relation to clinicopathologic and disease biology characteristics of both early and late gastro-oesophageal cancer. This data will be collected through data-linkage to medical records. This exploratory outcome are assessed by the use of statistical analytics software SAS to analyse the data and prepare regular reports on patient outcomes.
Timepoint [1] 382035 0
6 monthly for 10 years
Secondary outcome [2] 382036 0
Collection of patient outcome data in relation to treatment strategies via data linkage to medical records. This exploratory outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare regular reports on patient treatment strategies.
Timepoint [2] 382036 0
6 monthly for 10 years
Secondary outcome [3] 382040 0
Collection of patient characteristic data of those that did not receive any anti-cancer systemic treatment for late stage gastro-oesophageal cancers. This data will be collected through data-linkage to medical records. This exploratory outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare regular reports on patient characteristics.
Timepoint [3] 382040 0
6 monthly for 10 years
Secondary outcome [4] 382041 0
Collection of patient outcome data in relation to overall survival of patients with late stage gastro-oesophageal cancer via data linkage to medical records. This exploratory outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare regular reports on overall survival.
Timepoint [4] 382041 0
6 monthly for 10 years

Eligibility
Key inclusion criteria
1. Any patient with gastro-oesophageal cancer within 3 months of diagnosis.
2. Age over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be utilized when comparing clinical characteristics between groups. Chi-square and Fisher’s test will be used to test associations. The Kaplan-Meier method will be used for survival analyses. The stratified log rank test will be used to compare survival curves between different subgroups of participants, and p-values of 0.05 will be considered significant. Regression analysis may also be used in univariate and multivariate analysis for relevant associations. Identifiable data will not be used during analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2030
Actual
Date of last data collection
Anticipated
2/07/2040
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16471 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 16473 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 16474 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 30011 0
3000 - Melbourne
Recruitment postcode(s) [2] 30013 0
3011 - Footscray
Recruitment postcode(s) [3] 30014 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 305466 0
Other Collaborative groups
Name [1] 305466 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Country [1] 305466 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Address
1G Royal Parade
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 305864 0
None
Name [1] 305864 0
Address [1] 305864 0
Country [1] 305864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305781 0
Melbourne Health HREC
Ethics committee address [1] 305781 0
Ethics committee country [1] 305781 0
Australia
Date submitted for ethics approval [1] 305781 0
Approval date [1] 305781 0
02/04/2020
Ethics approval number [1] 305781 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101578 0
Prof Peter Gibbs
Address 101578 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 101578 0
Australia
Phone 101578 0
+61 3 9345 2555
Fax 101578 0
Email 101578 0
[email protected]
Contact person for public queries
Name 101579 0
Nicole Ng
Address 101579 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 101579 0
Australia
Phone 101579 0
+61 3 9345 2555
Fax 101579 0
Email 101579 0
[email protected]
Contact person for scientific queries
Name 101580 0
Margaret Lee
Address 101580 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 101580 0
Australia
Phone 101580 0
+61 3 9345 2555
Fax 101580 0
Email 101580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The aim of this project is to improve our understanding of the treatment and outcomes of gastro-oesophageal cancer. Data from participating sites will be combined for analysis. Therefore, IPD will not be relevant for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.