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
ACTRN12625000077460
Ethics application status
Approved
Date submitted
4/02/2025
Date registered
4/02/2025
Date last updated
11/02/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ANZCTR-374 20250131 Test Create
Scientific title
ANZCTR-374 20250131 Test Create
Secondary ID [1] 313804 0
12314145
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 336440 0
Condition category
Condition code
Blood 332961 332961 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 330393 0
Early detection / Screening
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 340499 0
test
Timepoint [1] 340499 0
test
Secondary outcome [1] 444271 0
test
Timepoint [1] 444271 0
test

Eligibility
Key inclusion criteria
test
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
test
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
test
Masking / blinding
Open (masking not used)
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
14/03/2025
Actual
Date of last participant enrolment
Anticipated
20/03/2025
Actual
Date of last data collection
Anticipated
30/03/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27522 0
The Hills Clinic - Kellyville
Recruitment postcode(s) [1] 43634 0
2155 - Kellyville

Funding & Sponsors
Funding source category [1] 318271 0
Government body
Name [1] 318271 0
test
Country [1] 318271 0
Australia
Primary sponsor type
Hospital
Name
Test
Address
Country
Australia
Secondary sponsor category [1] 320659 0
None
Name [1] 320659 0
Address [1] 320659 0
Country [1] 320659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316911 0
ACU Human Research Ethics Committee
Ethics committee address [1] 316911 0
Ethics committee country [1] 316911 0
Australia
Date submitted for ethics approval [1] 316911 0
01/02/2025
Approval date [1] 316911 0
01/02/2025
Ethics approval number [1] 316911 0

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

Contacts
Principal investigator
Name 139410 0
Mr Nathan Leung
Address 139410 0
test
Country 139410 0
Australia
Phone 139410 0
+61 412345678
Fax 139410 0
Email 139410 0
[email protected]
Contact person for public queries
Name 139411 0
Nathan Leung
Address 139411 0
test
Country 139411 0
Australia
Phone 139411 0
+61 412345678
Fax 139411 0
Email 139411 0
[email protected]
Contact person for scientific queries
Name 139412 0
Nathan Leung
Address 139412 0
test
Country 139412 0
Australia
Phone 139412 0
+61 412345678
Fax 139412 0
Email 139412 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
Conditions for requesting access:
• No requirements
What individual participant data will be or are expected to be shared?
• De-identified Individual participant data for:
• All outcomes data
What types of analyses could be conducted using the individual participant data?
• Systematic reviews and meta-analyses
• Health economic analyses
• Teaching research methods or developing new statistical techniques
When might the individual participant data become available to request access, and for how long?
From:
01/02/2025
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: 1. test line 1 2. test line 2 3. test line 3

• Data sharing request system: 1. test line 1 2. test line 2 3. test line 3

• Journal publication or its supplementary materials: 1. test line 1 2. test line 2 3. test line 3

• Email of trial custodian, sponsor or committee: 1. test line 1 2. test line 2 3. test line 3

• Postal Address: 1. test line 1 2. test line 2 3. test line 3

Are there additional conditions or steps involved in requesting or accessing individual participant data?
Yes: test

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Test data share
When will data be available (start and end dates)?
test start end
Available to whom?
test available to
Available for what types of analyses?
test analyses
How or where can data be obtained?
test data obtained


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.