Trial Review

This is a test website


Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

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
ACTRN12625000080426p
Ethics application status
Not yet submitted
Date submitted
12/02/2025
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Step 11 IPD testing - 12022025 - Yes IPD registrate
Scientific title
Step 11 IPD testing - 12022025 - Yes IPD registrate
Secondary ID [1] 313813 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Step 11 IPD testing - 12022025 - Yes IPD registrate 336447 0
Condition category
Condition code
Inflammatory and Immune System 332968 332968 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Intervention code [1] 330400 0
Treatment: Devices
Comparator / control treatment
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Control group
Active

Outcomes
Primary outcome [1] 340506 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Timepoint [1] 340506 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Secondary outcome [1] 444278 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Timepoint [1] 444278 0
Step 11 IPD testing - 12022025 - Yes IPD registrate

Eligibility
Key inclusion criteria
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate
Step 11 IPD testing - 12022025 - Yes IPD registrate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Step 11 IPD testing - 12022025 - Yes IPD registrate
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Step 11 IPD testing - 12022025 - Yes IPD registrate
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 318280 0
University
Name [1] 318280 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Country [1] 318280 0
Australia
Primary sponsor type
University
Name
Step 11 IPD testing - 12022025 - Yes IPD registrate
Address
Country
Australia
Secondary sponsor category [1] 320668 0
None
Name [1] 320668 0
Address [1] 320668 0
Country [1] 320668 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316920 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316920 0
Ethics committee country [1] 316920 0
Australia
Date submitted for ethics approval [1] 316920 0
07/10/2025
Approval date [1] 316920 0
Ethics approval number [1] 316920 0

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

Contacts
Principal investigator
Name 139446 0
Dr Step 11 IPD testing - 12022025 - Yes IPD registrate
Address 139446 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Country 139446 0
Australia
Phone 139446 0
+61 2 9562 5333
Fax 139446 0
Email 139446 0
[email protected]
Contact person for public queries
Name 139447 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Address 139447 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Country 139447 0
Australia
Phone 139447 0
+61 2 9562 5333
Fax 139447 0
Email 139447 0
[email protected]
Contact person for scientific queries
Name 139448 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Address 139448 0
Step 11 IPD testing - 12022025 - Yes IPD registrate
Country 139448 0
Australia
Phone 139448 0
+61 2 9562 5333
Fax 139448 0
Email 139448 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:
• Anyone

• Researchers

• 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

• 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

What individual participant data will be or are expected to be shared?
• De-identified Individual participant data for:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
• Individual participant data not covered above: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

What types of analyses could be conducted using the individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

When might the individual participant data become available to request access, and for how long?
From:
21/10/2026
To:
A finite period of: years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate2. Step 11 IPD testing - 12022025 - Yes IPD registrate

• Data sharing request system: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate2. Step 11 IPD testing - 12022025 - Yes IPD registrate3. Step 11 IPD testing - 12022025 - Yes IPD registrate4. Step 11 IPD testing - 12022025 - Yes IPD registrate5. Step 11 IPD testing - 12022025 - Yes IPD registrate

• Journal publication or its supplementary materials: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate2. Step 11 IPD testing - 12022025 - Yes IPD registrate3. Step 11 IPD testing - 12022025 - Yes IPD registrate4. Step 11 IPD testing - 12022025 - Yes IPD registrate

• Email of trial custodian, sponsor or committee: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate2. Step 11 IPD testing - 12022025 - Yes IPD registrate3. Step 11 IPD testing - 12022025 - Yes IPD registrate

• Postal Address: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

• 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate

Are there additional conditions or steps involved in requesting or accessing individual participant data?
Yes: 1. Step 11 IPD testing - 12022025 - Yes IPD registrate 2. Step 11 IPD testing - 12022025 - Yes IPD registrate 3. Step 11 IPD testing - 12022025 - Yes IPD registrate 4. Step 11 IPD testing - 12022025 - Yes IPD registrate 5. Step 11 IPD testing - 12022025 - Yes IPD registrate

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.