Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000076471
Ethics application status
Approved
Date submitted
1/02/2025
Date registered
1/02/2025
Date last updated
18/02/2025
Date data sharing statement initially provided
1/02/2025
Date results provided
1/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZCTR-374 Test 20250131
Scientific title
ANZCTR-374 Test 20250131
Secondary ID [1] 310516 0
2132145352634635
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 331319 0
Condition category
Condition code
Cancer 328075 328075 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
test
Intervention code [1] 326907 0
Diagnosis / Prognosis
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 335941 0
test
Timepoint [1] 335941 0
03/09/2023
Secondary outcome [1] 426218 0
test
Timepoint [1] 426218 0
01/09/2023

Eligibility
Key inclusion criteria
test
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
19/09/2025
Actual
Sample size
Target
1000
Accrual to date
2000
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 25477 0
Sutherland Heart Clinic - Caringbah
Recruitment postcode(s) [1] 41289 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 314718 0
Hospital
Name [1] 314718 0
test
Country [1] 314718 0
Australia
Primary sponsor type
Government body
Name
test
Address
Country
Australia
Secondary sponsor category [1] 316689 0
University
Name [1] 316689 0
test
Address [1] 316689 0
Country [1] 316689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313728 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 313728 0
Ethics committee country [1] 313728 0
Australia
Date submitted for ethics approval [1] 313728 0
22/08/2024
Approval date [1] 313728 0
22/08/2024
Ethics approval number [1] 313728 0

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

Contacts
Principal investigator
Name 129162 0
Mr Nathan Leung
Address 129162 0
test
Country 129162 0
Australia
Phone 129162 0
+61 412345678
Fax 129162 0
Email 129162 0
[email protected]
Contact person for public queries
Name 129163 0
Nathan Leung
Address 129163 0
test
Country 129163 0
Australia
Phone 129163 0
+61 412345678
Fax 129163 0
Email 129163 0
[email protected]
Contact person for scientific queries
Name 129164 0
Nathan Leung
Address 129164 0
test
Country 129164 0
Australia
Phone 129164 0
+61 412345678
Fax 129164 0
Email 129164 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• test other access update

Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee

• test other participants update

What individual participant data will be or are expected to be shared?
• De-identified Individual participant data for:
• Individual participant data not covered above: test sharing

What types of analyses could be conducted using the individual participant data?
• Studies exploring new research questions
• Test other analyses

When might the individual participant data become available to request access, and for how long?
From:
Test Other From

To:
13/02/2025
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: Test Materials

• test obtain

Are there additional conditions or steps involved in requesting or accessing individual participant data?
No
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
test sharing
When will data be available (start and end dates)?
test start end
Available to whom?
test available
Available for what types of analyses?
test analyses
How or where can data be obtained?
test obtain


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24482Analytic codetest   386526-(Uploaded-22-08-2024-14-15-26)-test.pdf
24483Other https://google.com.au  386526-(Uploaded-22-08-2024-14-48-05)-test_image.jpg
24484Data dictionary    386526-(Uploaded-22-08-2024-14-48-05)-test_image.jpg



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.