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Trial registered on ANZCTR


Registration number
ACTRN12624001321538
Ethics application status
Approved
Date submitted
2/12/2024
Date registered
4/12/2024
Date last updated
4/12/2024
Date data sharing statement initially provided
4/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Test ANZCTR-11 20241126-2
Scientific title
Test ANZCTR-11 20241126-2
Secondary ID [1] 313283 0
2132145352634635
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 335607 0
Condition category
Condition code
Blood 332173 332173 0 0
Anaemia

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] 329857 0
Not applicable
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 339765 0
test
Timepoint [1] 339765 0
test
Secondary outcome [1] 441164 0
test
Timepoint [1] 441164 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
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2024
Actual
Date of last participant enrolment
Anticipated
21/12/2024
Actual
Date of last data collection
Anticipated
3/01/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27294 0
The Hills Clinic - Kellyville
Recruitment postcode(s) [1] 43381 0
2155 - Kellyville

Funding & Sponsors
Funding source category [1] 317732 0
Hospital
Name [1] 317732 0
test
Country [1] 317732 0
Australia
Primary sponsor type
Government body
Name
Test
Address
Country
Australia
Secondary sponsor category [1] 320047 0
None
Name [1] 320047 0
Address [1] 320047 0
Country [1] 320047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316425 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 316425 0
Ethics committee country [1] 316425 0
Australia
Date submitted for ethics approval [1] 316425 0
27/11/2024
Approval date [1] 316425 0
27/11/2024
Ethics approval number [1] 316425 0

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

Contacts
Principal investigator
Name 137838 0
Mr Nathan Leung
Address 137838 0
test
Country 137838 0
Australia
Phone 137838 0
+61 412345678
Fax 137838 0
Email 137838 0
[email protected]
Contact person for public queries
Name 137839 0
Nathan Leung
Address 137839 0
test
Country 137839 0
Australia
Phone 137839 0
+61 412345678
Fax 137839 0
Email 137839 0
[email protected]
Contact person for scientific queries
Name 137840 0
Nathan Leung
Address 137840 0
test
Country 137840 0
Australia
Phone 137840 0
+61 412345678
Fax 137840 0
Email 137840 0
[email protected]

Data sharing statement
Would sharing individual participant data from this study be considered?
Yes
Data Eligibility and Access Conditions?
Who is eligible to request access to the individual participant data?
Would there be any conditions for requesting access to individual participant data?
Requires a scientifically sound proposal or protocol
Other:
other details

What individual participant data might be shared?
De-identified Individual participant data for: Primary outcome(s) Other data:
other de-identified

What types of analyses may be considered for the individual participant data?
Evidence synthesis, including for systematic reviews, meta-analyses, etc.
When might the individual participant data become available to request access, and for how long?
From:
After completion of first data analysis
To:
Not yet decided
Where can requests for access to individual participant data be made, or where could individual participant data be obtained directly?
Data sharing request system URL/DOI test request system
Would there be any additional conditions or processes regarding requests for and access to individual participant data?
question 7 input
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
test reason


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.