Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000914268
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
30/05/2018
Date last updated
5/07/2022
Date data sharing statement initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a database and biobank facility for the collection of clinical data and the storage of biological samples, such as tissue, blood and urine, in patients with bladder and urothelial cancer (BLADDA).
Scientific title
Development of a database and biobank facility for the collection of clinical data and the storage of biological samples, such as tissue, blood and urine, in patients with bladder and urothelial cancer (BLADDA).
Secondary ID [1] 294060 0
None
Universal Trial Number (UTN)
Trial acronym
BLADDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 306617 0
Condition category
Condition code
Cancer 305716 305716 0 0
Bladder

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 muscle-invasive or metastatic bladder (urothelial or non-urothelial) cancer 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, patients will also undergo collection of tissue, blood and urine at several time points
Intervention code [1] 300336 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304794 0
Proportion of patients with muscle invasive or metastatic bladder cancer in Australia that are recurrence free after local treatment. This outcome is being assessed from each patient's medical record.
Timepoint [1] 304794 0
Data will be collected at up to 6 time points for a maximum of 4 years: diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Primary timepoint is at the end of the 4 year data collection period.
Primary outcome [2] 304795 0
Proportion of patients with muscle invasive or metastatic bladder cancer in Australia that are recurrence free after systemic treatment. This outcome is being assessed from each patient's medical record.
Timepoint [2] 304795 0
Data will be collected at up to 6 time points for a maximum of 4 years: diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Primary timepoint is at the end of the 4 year data collection period.
Secondary outcome [1] 343219 0
Overall survival of patients with muscle invasive or metastatic bladder cancer in Australia after treatment. This outcome is being assessed from each patient's medical record.
Timepoint [1] 343219 0
Data will be collected at up to 6 time points for a maximum of 4 years: diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Timepoint is at the end of the 4 year data collection period.
Secondary outcome [2] 347491 0
Number of new prognostic and predictive biomarkers for bladder cancer 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] 347491 0
Timepoint is at the end of the 4 year data collection period.

Eligibility
Key inclusion criteria
Patients must meet the following criteria to be eligible for inclusion in this protocol:
Any patient with muscle-invasive or metastatic bladder (urothelial or non-urothelial) cancer.
Age 18 years or above.

If consent to the collection of blood and urine samples:
Able to undergo collection of blood and/or urine specimens.
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
1/06/2018
Actual
26/03/2018
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
300
Accrual to date
953
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10028 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 10029 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 10030 0
Western Hospital - Footscray - Footscray
Recruitment hospital [4] 10031 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 10032 0
Epworth Freemasons - Melbourne
Recruitment hospital [6] 10048 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 13677 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [8] 16536 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [9] 16537 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [10] 22694 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [11] 22695 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 37972 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 30093 0
2298 - Waratah
Recruitment postcode(s) [3] 30092 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 19354 0
3000 - Melbourne
Recruitment postcode(s) [5] 19357 0
3002 - Melbourne
Recruitment postcode(s) [6] 19355 0
3011 - Footscray
Recruitment postcode(s) [7] 19353 0
3050 - Parkville
Recruitment postcode(s) [8] 26361 0
3065 - Fitzroy
Recruitment postcode(s) [9] 19356 0
3084 - Heidelberg
Recruitment postcode(s) [10] 21564 0
3128 - Box Hill
Recruitment postcode(s) [11] 37973 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 298685 0
Other Collaborative groups
Name [1] 298685 0
Walter and Eliza Hall Institute for Medical Research
Country [1] 298685 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute for Medical Research
Address
1G Royal Parade
Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 297856 0
None
Name [1] 297856 0
Address [1] 297856 0
Country [1] 297856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299639 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299639 0
Royal Melbourne Hospital
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 299639 0
Australia
Date submitted for ethics approval [1] 299639 0
10/11/2017
Approval date [1] 299639 0
19/12/2017
Ethics approval number [1] 299639 0
HREC/17/MH/386

Summary
Brief summary
The purpose of this study is to determine whether certain biomarkers have an impact on the effectiveness of treatment of bladder cancer.

Who is it for?
You may be eligible for this study if you are over the age of 18 and have been diagnosed with muscle invasive bladder cancer or metastatic bladder cancer.

Study details
All participants will be required to give blood and urine samples at predetermined time points while completing their own cancer treatment. Where possible, blood collection will be at the same time as routine blood tests to reduce the number of times blood is taken. If there is left over tissue after planned medical procedures then a sample of this tissue will be kept. The blood, urine and tissue samples will then be tested to determine how the cells, genes and immune system interact with the cancer and whether these relate to treatment results.

It is hoped that this research will help us to better understand why some bladder cancers are more aggressive than other and also why some treatments work better in some patients than others.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81130 0
Dr Ben Tran
Address 81130 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 81130 0
Australia
Phone 81130 0
+61 3 8559 7810
Fax 81130 0
+61 3 8559 7739
Email 81130 0
ben.tran@petermac.org.au
Contact person for public queries
Name 81131 0
Dr Ben Tran
Address 81131 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 81131 0
Australia
Phone 81131 0
+61 3 8559 7810
Fax 81131 0
+61 3 8559 7739
Email 81131 0
ben.tran@petermac.org.au
Contact person for scientific queries
Name 81132 0
Dr Ben Tran
Address 81132 0
Medical Oncology
Peter MacCallum Cancer Centre
305 Grattan St Melbourne Vic 3000
Country 81132 0
Australia
Phone 81132 0
+61 3 8559 7810
Fax 81132 0
+61 3 8559 7739
Email 81132 0
ben.tran@petermac.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy. Non-interventional 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.