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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
13/08/2018
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 4820 0
New Zealand
State/province [1] 4820 0

Funding & Sponsors
Funding source category [1] 286616 0
Other Collaborative groups
Name [1] 286616 0
Australasian Leukaemia and Lymphoma Group (ALLG)
Address [1] 286616 0
Ground Floor, 35 Elizabeth Street. Richmond, VIC Australia, 3121
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
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
cecily.forsyth@healthemail.net.au
Contact person for public queries
Name 37315 0
Ms 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
delaine.smith@allg.org.au
Contact person for scientific queries
Name 37316 0
Dr 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
cecily.forsyth@healthemail.net.au

No information has been provided regarding IPD availability
Summary results
No Results