Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001592134
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
19/11/2019
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ACCORD-CRC: Australian Comprehensive Cancer Outcomes and Research Database: COLORECTAL
Scientific title
ACCORD-CRC: Australian Comprehensive Cancer Outcomes and Research Database: COLORECTAL
Secondary ID [1] 299366 0
Nil
Universal Trial Number (UTN)
Not applicable
Trial acronym
ACCORD-CRC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 314520 0
Condition category
Condition code
Cancer 312866 312866 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
Data collected will include:
• Patient demographics and characteristics
• Disease clinicopathological and molecular features
• Treatment history
• Outcomes and survival
• Follow-up data at 3 to 6-montly intervals until death

There is no participant contact for clinical data collection as a waiver of consent is in place.
Participants will be asked to consent to any removed cancer samples being stored in tissue bank.
Intervention code [1] 315628 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321476 0
Clinical data collection target of 10,000 colorectal cancer (CRC) patients as assessed by CRC registry data. This outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare regular reports on the target numbers.
Timepoint [1] 321476 0
10 years
Secondary outcome [1] 375898 0
Biospecimen collection target of 10,000 patients with colorectal cancer as assessed by CRC registry data. This outcome is assessed by the use of statistical analytics software SAS to analyse and prepare regular reports on the target number of biospecimens.
Timepoint [1] 375898 0
10 years
Secondary outcome [2] 376655 0
Collection of patient outcome data in relation to their disease characteristics. This outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare reporting on patient disease characteristics.
Timepoint [2] 376655 0
10 years
Secondary outcome [3] 376656 0
Collection of patient outcome data in relation to their treatment strategies. This outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare reporting on patient treatment strategies.
Timepoint [3] 376656 0
10 years
Secondary outcome [4] 376862 0
Collection of patient outcome data in relation to their treatment outcomes. This outcome is assessed by the use of statistical analytics software SAS to analyse the data and prepare reporting on patient treatment outcomes.
Timepoint [4] 376862 0
10 Years

Eligibility
Key inclusion criteria
Patients with colorectal (including appendiceal) adenocarcinoma.
Minimum age
16 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
Both
Statistical methods / analysis
Data from participating sites will be combined for analysis. When requested, participating clinicians will be provided with access to their own data (individual or hospital), and will thus be able to compare their practice with the aggregate data as a performance evaluation measure. Descriptive statistics will be used when comparing clinical characteristics between groups. Chi-square or Fisher’s test will be used to test associations. The Kaplan-Meier method will be used for survival analyses. Regression analysis may also be used in univariate and multivariate analysis for relevant associations. Identifiable data will not be used during the analysis phase.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14838 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 14840 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 14841 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 14842 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 14843 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 14844 0
The Northern Hospital - Epping
Recruitment hospital [7] 14845 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 28092 0
3050 - Parkville
Recruitment postcode(s) [2] 28094 0
3011 - Footscray
Recruitment postcode(s) [3] 28095 0
3021 - St Albans
Recruitment postcode(s) [4] 28096 0
3128 - Box Hill
Recruitment postcode(s) [5] 28097 0
3000 - Melbourne
Recruitment postcode(s) [6] 28098 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 303883 0
Other Collaborative groups
Name [1] 303883 0
The Walter and Eliza Hall Institute of Medical Research
Country [1] 303883 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 304024 0
None
Name [1] 304024 0
Not applicable
Address [1] 304024 0
Not applicable
Country [1] 304024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304387 0
Melbourne Health HREC
Ethics committee address [1] 304387 0
Melbourne Health
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria 3052
Ethics committee country [1] 304387 0
Australia
Date submitted for ethics approval [1] 304387 0
29/05/2019
Approval date [1] 304387 0
06/08/2019
Ethics approval number [1] 304387 0

Summary
Brief summary
The purpose of this study is to create a database of colorectal cancer patients.

Who is it for?
You may be eligible for this study if you are aged 16 or over, have colorectal cancer and are a patient at one of the participating sites.

Study details
This is an observational study, aiming to collect information and tissue samples on consecutive colorectal cancer (CRC) patients at participating sites over at least 10 years.
All participants will be asked to consent to any removed cancer samples being stored in tissue bank.
It is hoped this research will provide important information about all patients with colorectal cancer in routine clinical practice (in the real world).
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 96778 0
Prof Peter Gibbs
Address 96778 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 96778 0
Australia
Phone 96778 0
+61 3 9345 2555
Fax 96778 0
Email 96778 0
[email protected]
Contact person for public queries
Name 96779 0
Mr Michael Harold
Address 96779 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 96779 0
Australia
Phone 96779 0
+61 3 9345 2555
Fax 96779 0
Email 96779 0
[email protected]
Contact person for scientific queries
Name 96780 0
Dr Hui-Li Wong
Address 96780 0
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 96780 0
Australia
Phone 96780 0
+61 3 9345 2555
Fax 96780 0
Email 96780 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
IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponsor level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.


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.