Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000929202
Ethics application status
Approved
Date submitted
30/05/2018
Date registered
1/06/2018
Date last updated
5/07/2022
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a database to collect clinical data, and where available associated tumour tissue samples, from patients with Renal Cell Carcinoma (KRAB).
Scientific title
Development of a database to collect clinical data, and where available associated tumour tissue samples, from patients with Renal Cell Carcinoma (KRAB).
Secondary ID [1] 295043 0
None
Universal Trial Number (UTN)
Trial acronym
KRAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 308086 0
Condition category
Condition code
Cancer 307130 307130 0 0
Kidney

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enrolled patients diagnosed with metastatic renal cell carcinoma will undergo collection of clinical data and archival tumour specimens. Clinical data collected includes: patient demographics and characteristics, disease clinicopathological and molecular features, treatment history, outcomes and survival. Data will be collected regularly throughout the patient's treatment and follow up until death. Where applicable, archival tumour specimens will also be utilised.
Intervention code [1] 301379 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306085 0
Proportion of patients with Renal Cell Carcinoma in Australia that are recurrence free after treatment. This outcome is being assessed from each patient's medical record.
Timepoint [1] 306085 0
Data will be collected every 3 to 6 months for a maximum of 4 years:
• Disease clinicopathological and molecular features
• Treatment history including local and systemic therapies
• Surveillance methods
• Outcomes and survival
Primary timepoint is at the end of the 4 year data collection period.
Primary outcome [2] 306087 0
Number of new prognostic biomarkers for Renal Cell Carcinoma identified. Outcome is assessed using the following techniques:
• Multiplexed microarrays, used to determine relative expression changes
• Quantitative PCR, used to measure copy numbers of genes and determine relative expression changes
• Immunohistochemistry to identify expression of proteins
• Next generation sequencing, used to determine mutations present in germ cell cancers or germline SNPs
• Proteomics analysis
• Other novel methodologies not yet identified.
Timepoint [2] 306087 0
Primary timepoint is at the end of the 4 year data collection period.
Secondary outcome [1] 347523 0
Overall survival of patients with Renal Cell Carcinoma in Australia after treatment. This outcome is being assessed from each patient's medical record.
Timepoint [1] 347523 0
Timepoint is at the end of the 4 year data collection period.

Eligibility
Key inclusion criteria
Any patient 18 years old or above with metastatic RCC
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
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
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-Meir method will be used for survival analyses. Regression analysis may also be used in univariate and multivariate analysis for relevant associations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
6/07/2018
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
400
Accrual to date
321
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 11043 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [2] 11044 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 11045 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 11046 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 11047 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 11048 0
Western Hospital - Footscray - Footscray
Recruitment hospital [7] 11049 0
Sunshine Hospital - St Albans
Recruitment hospital [8] 14101 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 22701 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [10] 22702 0
The Canberra Hospital - Garran
Recruitment hospital [11] 22703 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [12] 22704 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 22839 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 22840 0
3084 - Heidelberg
Recruitment postcode(s) [3] 22841 0
3128 - Box Hill
Recruitment postcode(s) [4] 22842 0
3000 - Melbourne
Recruitment postcode(s) [5] 22843 0
2298 - Waratah
Recruitment postcode(s) [6] 22844 0
3011 - Footscray
Recruitment postcode(s) [7] 22845 0
3021 - St Albans
Recruitment postcode(s) [8] 26892 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 37979 0
2560 - Campbelltown
Recruitment postcode(s) [10] 37980 0
2605 - Garran
Recruitment postcode(s) [11] 37981 0
3168 - Clayton
Recruitment postcode(s) [12] 37982 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299626 0
Other Collaborative groups
Name [1] 299626 0
Walter and Eliza Hall Institute for Medical Research
Country [1] 299626 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute for Medical Research
Address
1G Royal Parade Parkville 3052 Victoria
Country
Australia
Secondary sponsor category [1] 298952 0
None
Name [1] 298952 0
Address [1] 298952 0
Country [1] 298952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300526 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300526 0
Ethics committee country [1] 300526 0
Australia
Date submitted for ethics approval [1] 300526 0
09/05/2018
Approval date [1] 300526 0
18/06/2018
Ethics approval number [1] 300526 0

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

Contacts
Principal investigator
Name 83942 0
Dr Ben Tran
Address 83942 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 83942 0
Australia
Phone 83942 0
+61 3 8559 7810
Fax 83942 0
+61 3 8559 7739
Email 83942 0
[email protected]
Contact person for public queries
Name 83943 0
Ben Tran
Address 83943 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 83943 0
Australia
Phone 83943 0
+61 3 8559 7810
Fax 83943 0
+61 3 8559 7739
Email 83943 0
[email protected]
Contact person for scientific queries
Name 83944 0
Ben Tran
Address 83944 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 83944 0
Australia
Phone 83944 0
+61 3 8559 7810
Fax 83944 0
+61 3 8559 7739
Email 83944 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.