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Trial registered on ANZCTR


Registration number
ACTRN12617000051347
Ethics application status
Approved
Date submitted
9/01/2017
Date registered
11/01/2017
Date last updated
28/04/2022
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Haemoglobinopathy Registry
Scientific title
Haemoglobinopathy Registry
Secondary ID [1] 290851 0
None
Universal Trial Number (UTN)
Trial acronym
HbR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thalassaemia 301531 0
Sickle cell disease 301532 0
Condition category
Condition code
Blood 301252 301252 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
This is a patient Registry collecting information on patients with a diagnosis of sickle cell disease, alpha-thalassemia, beta-thalassemia and other haemoglobinopathies. Information will be collected by review of medical records for a period of twenty years.
Intervention code [1] 296795 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300667 0
Survival assessed by review of hospital medical records
Timepoint [1] 300667 0
five years
Secondary outcome [1] 330564 0
Variation in treatment assessed by hospital records
Timepoint [1] 330564 0
five years

Eligibility
Key inclusion criteria
Patients with a diagnosis of sickle cell disease, alpha-thalassemia, beta-thalassemia and other haemoglobinopathies.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who have chosen to opt-off the registry.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
A detailed pre-determined statistical plan will be developed prior to planned analyses of registry data.

Analysis plans will be reviewed by the Steering Committee and by a suitably qualified statistician prior to data from the Haemoglobinopathy Registry being analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/01/2014
Date of last participant enrolment
Anticipated
31/12/2032
Actual
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
1000
Accrual to date
782
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 7229 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 7230 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 7231 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 7232 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [5] 7233 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [6] 7235 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [7] 7236 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 7237 0
Prince of Wales Hospital - Randwick
Recruitment hospital [9] 7238 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [10] 12466 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [11] 22271 0
Liverpool Hospital - Liverpool
Recruitment hospital [12] 22272 0
Mater Hospital Yeppoon - Yeppoon
Recruitment postcode(s) [1] 14994 0
3168 - Clayton
Recruitment postcode(s) [2] 14995 0
3052 - Parkville
Recruitment postcode(s) [3] 14996 0
2050 - Camperdown
Recruitment postcode(s) [4] 14997 0
2145 - Westmead
Recruitment postcode(s) [5] 14998 0
4101 - South Brisbane
Recruitment postcode(s) [6] 15000 0
6008 - Subiaco
Recruitment postcode(s) [7] 15001 0
5000 - Adelaide
Recruitment postcode(s) [8] 15002 0
2031 - Randwick
Recruitment postcode(s) [9] 15003 0
5006 - North Adelaide
Recruitment postcode(s) [10] 37433 0
2170 - Liverpool
Recruitment postcode(s) [11] 37434 0
4703 - Yeppoon

Funding & Sponsors
Funding source category [1] 295286 0
Commercial sector/Industry
Name [1] 295286 0
Celgene Pty Ltd provided initial funding, but this funding ceased as of 31/12/2018
Country [1] 295286 0
Australia
Funding source category [2] 311328 0
University
Name [2] 311328 0
Monash University
Country [2] 311328 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 294107 0
None
Name [1] 294107 0
Address [1] 294107 0
Country [1] 294107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296618 0
Monash Health HREC
Ethics committee address [1] 296618 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [1] 296618 0
Australia
Date submitted for ethics approval [1] 296618 0
07/11/2013
Approval date [1] 296618 0
19/12/2013
Ethics approval number [1] 296618 0
Monash Health HREC Ref: 13372A
Ethics committee name [2] 296619 0
Royal Children's Hospital HREC
Ethics committee address [2] 296619 0
50 Flemington Road
Parkville Victoria 3052
Ethics committee country [2] 296619 0
Australia
Date submitted for ethics approval [2] 296619 0
29/05/2014
Approval date [2] 296619 0
19/12/2014
Ethics approval number [2] 296619 0
34123 A
Ethics committee name [3] 296620 0
Princess Margaret Hospital HREC
Ethics committee address [3] 296620 0
Roberts Rd,
Subiaco WA 6008
Ethics committee country [3] 296620 0
Australia
Date submitted for ethics approval [3] 296620 0
21/07/2016
Approval date [3] 296620 0
10/08/2016
Ethics approval number [3] 296620 0
2016095EP
Ethics committee name [4] 296621 0
Royal Prince Alfred Hospital HREC
Ethics committee address [4] 296621 0
Missenden Rd,
Camperdown NSW 2050
Ethics committee country [4] 296621 0
Australia
Date submitted for ethics approval [4] 296621 0
13/11/2013
Approval date [4] 296621 0
25/06/2014
Ethics approval number [4] 296621 0
HREC/13/RPAH/527
Ethics committee name [5] 310828 0
Monash Health HREC
Ethics committee address [5] 310828 0
Monash Medical Centre 246 Clayton Road Clayton, Victoria, 3168
Ethics committee country [5] 310828 0
Australia
Date submitted for ethics approval [5] 310828 0
17/05/2016
Approval date [5] 310828 0
21/07/2016
Ethics approval number [5] 310828 0
NMA: HREC/16/MonH/156

Summary
Brief summary
The primary purpose of this study is to provide long-term patient follow-up and review of clinical and correlative data outside of clinical trials.

Who is it for?
The registry will collect information on patients with a diagnosis of sickle cell disease, alpha-thalassemia, beta-thalassemia and other haemoglobinopathies.

Study Details
Treating clinicians at sites will identify patients and enrol them to the study. The following categories of data items will be collected to the Haemoglobinopathy database using a web portal:
Demographic details
Clinical presentation
Laboratory results
Therapy
Complications (of therapy or condition)
Outcomes

It is hoped that the findings from this study will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71450 0
Prof Erica Wood
Address 71450 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71450 0
Australia
Phone 71450 0
+61 3 99030051
Fax 71450 0
Email 71450 0
[email protected]
Contact person for public queries
Name 71451 0
Zoe McQuilten
Address 71451 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71451 0
Australia
Phone 71451 0
+61 3 99030379
Fax 71451 0
Email 71451 0
[email protected]
Contact person for scientific queries
Name 71452 0
Zoe McQuilten
Address 71452 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71452 0
Australia
Phone 71452 0
+61 3 99030379
Fax 71452 0
Email 71452 0
[email protected]

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


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.