Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000217404
Ethics application status
Approved
Date submitted
16/12/2024
Date registered
26/03/2025
Date last updated
26/03/2025
Date data sharing statement initially provided
26/03/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
TReatment of Australian Colorectal Cancer
– SELECTing biomarkers of Interest (TRACC-SELECT) in metastatic colorectal cancer patients
Scientific title
Real-world clinicopathologic presentation and TReatment of Australian Colorectal Cancer
– SELECTing biomarkers of Interest in metastatic colorectal cancer patients
Secondary ID [1] 313474 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 335883 0
Condition category
Condition code
Cancer 332469 332469 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The TRACC-SELECT study is a non-interventional registry designed for prospective data collection on specific biomarker defined subsets of patients with metastatic colorectal cancer. The indication for the registry are patients with recurrent and/or metastatic colorectal cancer with biomarkers of particular interest, including but not limited to deficient MMR, BRAF V600E mutant, KRAS G12C mutant, HER2, POLE and/or NTRK.
From each sub-group, an initial 25-50 patients will be enrolled from 10-15 sites in Australia. Recruitment will take place over a 10 year period from 2022 with a study end date of December 2032.
There is no direct involvement by patients and all data is collected from the patient medical record. The data collected will include patient characteristics, tumour characteristics, treatment for metastatic disease and molecular analysis as described above.
Intervention code [1] 330048 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340007 0
Clinicopathologic presentation
Timepoint [1] 340007 0
The clinicopathologic outcome is assessed at either time of initial primary cancer diagnosis (dMMR done by blood test) or at time of diagnosis of metastatic disease (the other biomarker testing is done on the metastatic tumour biopsy)
Primary outcome [2] 340515 0
Treatment selection
Timepoint [2] 340515 0
Initial diagnosis and subsequent change of therapy based on toxicity or progression of disease.
Secondary outcome [1] 442279 0
To determine progression free survival (PFS) for each line of therapy
Timepoint [1] 442279 0
Outcome assessed with 3 monthly CT scans during treatment
Secondary outcome [2] 442280 0
To assess overall survival (OS) for patients in routine clinical practice
Timepoint [2] 442280 0
Outcome assessed at date of last patient visit (date last known to be alive) or date of patient death

Eligibility
Key inclusion criteria
Patients eligible for enrolment on to study must meet the following criteria:
1. Patients greater than or equal to 18 years of age, with any Eastern Cooperative Oncology Group (ECOG) performance status and with histologically confirmed metastatic colorectal cancer (either de novo metastatic or relapsed) that harbour at least one of these biomarkers of interest
a) Deficient mismatch repair proteins (dMMR)
b) BRAF V600E mutation
c) KRAS G12C mutation
d) HER2 ISH positive
e) NTRK fusion (either IHC positive or NGS positive)
f) POLE mutation
g) FGFR2 amplification

2. Diagnosed with metastatic colorectal cancer after 1st January 2021

NB: Written informed consent from patients is not required for this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed prior to 1st January 2021

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2024
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
100
Accrual to date
79
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 317914 0
Other Collaborative groups
Name [1] 317914 0
The Walter and Eliza Hall Institute of Medical Research
Country [1] 317914 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 320259 0
None
Name [1] 320259 0
Address [1] 320259 0
Country [1] 320259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316600 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316600 0
Ethics committee country [1] 316600 0
Australia
Date submitted for ethics approval [1] 316600 0
29/06/2022
Approval date [1] 316600 0
14/09/2022
Ethics approval number [1] 316600 0

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

Contacts
Principal investigator
Name 138374 0
Prof Peter Gibbs
Address 138374 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville VIC 3052
Country 138374 0
Australia
Phone 138374 0
+61 3 9345 2555
Fax 138374 0
Email 138374 0
[email protected]
Contact person for public queries
Name 138375 0
Michael Harold
Address 138375 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville VIC 3052
Country 138375 0
Australia
Phone 138375 0
+61 3 9345 2799
Fax 138375 0
Email 138375 0
[email protected]
Contact person for scientific queries
Name 138376 0
Peter Gibbs
Address 138376 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville VIC 3052
Country 138376 0
Australia
Phone 138376 0
+61 3 9345 2555
Fax 138376 0
Email 138376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Only aggregated data provided for research



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.