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Trial registered on ANZCTR


Registration number
ACTRN12613000138785
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
5/02/2013
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Myeloproliferative Neoplasms Registry (ALLG MPN01)
Scientific title
Myeloproliferative Neoplasms Registry: A cancer registration scheme to aid in the planning of health service resources and cancer control programmes and the assessment of their efficacy
Secondary ID [1] 281832 0
ALLG MPN01
Universal Trial Number (UTN)
Trial acronym
ALLG MPN Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycythaemia vera (PV) 288188 0
Essential thrombocythaemia (ET) 288281 0
Primary myelofibrosis (PMF) 288282 0
Myeloproliferative neoplasm – unclassifiable (MPN-NOS) 288283 0
Chronic eosinophilic leukaemia (CEL) 288284 0
Hypereosinophilic syndrome (HES) 288285 0
Refractory anaemia with ring sideroblasts associated with marked thrombocytosis (RARS-t)
 288286 0
Condition category
Condition code
Cancer 288552 288552 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
0
Target follow-up type
Years
Description of intervention(s) / exposure
The MPNs have until recently been under-represented in malignant haematology research. With the major developments in MPN biology and emerging new pharmaceutical agents this is a major potential growth area for basic/translational research and clinical trials.

Currently, there is no co-ordinated approach to collect data on the numbers of MPN patients, and the current standards of care around Australia and New Zealand. This information is vital to planning and feasibility assessment for future clinical trials. A well-constructed database will generate useful data, as has been shown by international groups that have had high impact publications from retrospective data analysis.

The database will hopefully be a major resource for translational research, particularly if patients in the registry also consent to ALLG tissue banking. Investigators with an interest in a specific subset of MPN patients will be able to query the database for a list of such patients and their characteristics.

Data will be collected and entered online by registry physicians/sites at the time of diagnosis and annually for all patients enrolled on the registry. Physicians will be able to access the MPN Registry website at any time to enter and edit the data from their own patients, to access MPN registry documents or to view site-specific subject data reports. The registry will not be available for veiwing by the public or patients.

Registry data will be downloaded for review and analyses on a regular basis by the Registry Management Committee.

The registry will be ongoing.
Intervention code [1] 286388 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288710 0
Provide epidemiological and descriptive data on current patterns of diagnosis and treatment of MPNs
Timepoint [1] 288710 0
Continuous and ongoing once registry is established.
Secondary outcome [1] 300798 0
Estimate rates of key clinical events (thrombosis, haemorrhage, progression to MF/AML, death) and treatment response/intolerance
Timepoint [1] 300798 0
Continuous and ongoing once registry is established.
Secondary outcome [2] 300799 0
Perform central pathology review of blood and bone marrow to confirm the sub-classification of the bone marrow disorder
Timepoint [2] 300799 0
After baseline data collection
Secondary outcome [3] 300800 0
Establish collaborations with basic and translational research groups to provide access to a well-characterised MPN patient cohort
Timepoint [3] 300800 0
Continuous and ongoing once registry is established.
Secondary outcome [4] 300801 0
Provide investigators with data for planning and feasibility assessment of future clinical trials
Timepoint [4] 300801 0
Continuous and ongoing once registry is established.
Secondary outcome [5] 300802 0
Facilitate scientific projects and collection of samples for the Australasian Leukaemia and Lymphoma Group (ALLG) Tissue Bank
Timepoint [5] 300802 0
Continuous and ongoing once registry is established.

Eligibility
Key inclusion criteria
Patients recently (< 3 months) diagnosed with:
Essential Thrombocythaemia (ET)
Polycythaemia vera (PV)
Primary myelofibrosis (PMF)
Myeloproliferative neoplasm- unclassifiable
(Exceptions to this will be patients diagnosed with MPNs (PV, ET, PMF, MPN-NOS) at Gosford Hospital, Flinders Medical Centre or Austin Hospital after 1st January 2010, who will be eligible for participation retrospectively)

Patients with a new or pre-existing diagnosis of:
Chronic eosinophilic leukaemia (CES)
Hypereosinophilic syndrome (HES)
Refractory anaemia with ring sideroblasts associated with a marked thrombocytosis (RARS-t)

Aged 18 and over

Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/05/2013
Actual
22/04/2014
Date of last participant enrolment
Anticipated
31/07/2019
Actual
28/02/2017
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
300
Accrual to date
250
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14417 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 14418 0
The Canberra Hospital - Garran
Recruitment hospital [3] 14419 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 14420 0
Gosford Hospital - Gosford
Recruitment hospital [5] 14421 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 14422 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 14423 0
Nepean Hospital - Kingswood
Recruitment hospital [8] 14424 0
Orange Health Service - Orange
Recruitment hospital [9] 14425 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 14426 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 14427 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [12] 14428 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 14429 0
St George Hospital - Kogarah
Recruitment hospital [14] 14430 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 27427 0
3084 - Heidelberg
Recruitment postcode(s) [2] 27428 0
2605 - Garran
Recruitment postcode(s) [3] 27429 0
5042 - Bedford Park
Recruitment postcode(s) [4] 27430 0
2250 - Gosford
Recruitment postcode(s) [5] 27431 0
7000 - Hobart
Recruitment postcode(s) [6] 27432 0
2298 - Waratah
Recruitment postcode(s) [7] 27433 0
2747 - Kingswood
Recruitment postcode(s) [8] 27434 0
2800 - Orange
Recruitment postcode(s) [9] 27435 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 27436 0
3000 - Melbourne
Recruitment postcode(s) [11] 27437 0
2050 - Camperdown
Recruitment postcode(s) [12] 27438 0
6009 - Nedlands
Recruitment postcode(s) [13] 27439 0
2217 - Kogarah
Recruitment postcode(s) [14] 27440 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 286616 0
Other Collaborative groups
Name [1] 286616 0
Australasian Leukaemia and Lymphoma Group (ALLG)
Country [1] 286616 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group (ALLG)
Address
Ground Floor, 35 Elizabeth Street. Richmond, VIC Australia, 3121
Country
Australia
Secondary sponsor category [1] 285402 0
None
Name [1] 285402 0
N/A
Address [1] 285402 0
Country [1] 285402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288689 0
Ethics committee address [1] 288689 0
Ethics committee country [1] 288689 0
Date submitted for ethics approval [1] 288689 0
01/03/2013
Approval date [1] 288689 0
19/11/2013
Ethics approval number [1] 288689 0

Summary
Brief summary
The Myeloproliferative neoplasms (MPNs) have until recently been under-represented in malignant haematology research. Recent major developments in understanding MPN biology and emerging new pharmaceutical agents have resulted in MPNs being a major growth area for both basic/translational research and clinical trials.

Currently there is no systematic approach to collecting data on numbers of MPN patients and the current standards of care of these patients in Australia and New Zealand. This information is vital for planning and feasibility assessments for future clinical trials. A well-constructed database will generate essential data and be a major resource for translational research, particularly if patients in the registry also consent to ALLG tissue banking. Investigators with an interest in a specific subset of MPN patients will be able to query the database for a list of such patients and their characteristics.

Patients will be entered into the database either retrospectively (for certain diagnoses and some sites) or prospectively, at diagnosis, with annual follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37314 0
Dr Cecily Forsyth
Address 37314 0
Jarrett Street Specialist Centre
5/14-18 Jarrett Street
North Gosford
NSW 2250
Country 37314 0
Australia
Phone 37314 0
+61 2 4324 8488
Fax 37314 0
Email 37314 0
[email protected]
Contact person for public queries
Name 37315 0
Delaine Smith
Address 37315 0
Australasian Leukaemia & Lymphoma Group. Ground Floor, 35 Elizabeth Street, Richmond, VIC Australia, 3121
Country 37315 0
Australia
Phone 37315 0
+61 3 8373 9701
Fax 37315 0
Email 37315 0
[email protected]
Contact person for scientific queries
Name 37316 0
Cecily Forsyth
Address 37316 0
Jarrett Street Specialist Centre
5/14-18 Jarrett Street
North Gosford
NSW 2250
Country 37316 0
Australia
Phone 37316 0
+61 2 4324 8488
Fax 37316 0
Email 37316 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
No individual participant data will be publicly available as it is the aggregate data that is under investigation.


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
SourceTitleYear of PublicationDOI
EmbaseVariability of bone marrow biopsy reporting affects accuracy of diagnosis of myeloproliferative neoplasms: data from the ALLG MPN01 registry.2024https://dx.doi.org/10.1016/j.pathol.2023.09.012
N.B. These documents automatically identified may not have been verified by the study sponsor.