Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000337875
Ethics application status
Approved
Date submitted
16/03/2012
Date registered
23/03/2012
Date last updated
3/04/2024
Date data sharing statement initially provided
13/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry
Scientific title
Australasian Leukaemia and Lymphoma Group National Blood Cancer Registry
Secondary ID [1] 280158 0
ALLG NBCR
Universal Trial Number (UTN)
U1111-1125-0831
Trial acronym
ALLG NBCR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspected or Known or Diagnosed Blood Cancer 286107 0
Condition category
Condition code
Cancer 286279 286279 0 0
Leukaemia - Acute leukaemia
Public Health 286299 286299 0 0
Health service research
Cancer 307668 307668 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
15
Target follow-up type
Years
Description of intervention(s) / exposure
This study contains no assessments above those that would be offered as standard of care. Information from clinical investigations (including results obtained from testing on tissue samples collected at baseline as routine standard of care or testing of newly identified prognostic markers on excess tissue samples stored at baseline that are conducted to enhance treatment) will be periodically sent by staff at the treating site for inclusion on the registry database. If a patient is identified as suitable for an ALLG clinical trial by their treating physician, they will be approached for consent to this regisitry. Where the screening tests for the potential trial are the same and at the same timepoint as those in the registry, tests will not need to be repeated as information will be obtained from the registry database. Patients who are enrolled onto another clinical trial will remain in the registry, with periodic updates of disease status and treatment submitted to the registry by staff at the treating site, unless consent is withdrawn. Accrual to the registry is ongoing without any particular endpoint. When consent to registry is sought, patients will also be offered the opportunity to donate blood and bone marrow samples to the Australasian Leukaemia and Lymphoma Group (ALLG) Biobank, which stores samples and approves sample for use in suitable formal research applications in haematological malignancies.
Intervention code [1] 284485 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286743 0
To establish a common registration platform for patients with suspected blood cancer in Australia and New Zealand.
Timepoint [1] 286743 0
mid 2012 onwards
Primary outcome [2] 286744 0
To facilitate the participation of patients with blood cancers in ALLG clinical trials and ensure patients are enrolled in the trial most appropriate to their diagnosis.
Timepoint [2] 286744 0
mid 2012 onwards
Primary outcome [3] 286745 0
To improve the efficiency of data management for ALLG clinical trials by centralising data collection at baseline.
Timepoint [3] 286745 0
mid 2012 onwards
Secondary outcome [1] 296575 0
To promote a mechanism for centralised review of cytogenetic and molecular reporting where applicable.
Timepoint [1] 296575 0
mid 2012 onwards
Secondary outcome [2] 296576 0
To facilitate collection of blood cancer samples linked to clinical diagnostic, prognostic, treatment and outcome data.
Timepoint [2] 296576 0
mid 2012 onwards
Secondary outcome [3] 296577 0
To facilitate sample collection and review of bone marrow of patients with suspected relapsed blood cancer.
Timepoint [3] 296577 0
mid 2012 onwards
Secondary outcome [4] 296578 0
To develop the platform to provide information about the clinical profile, cytogenetic and molecular characteristics and treatment outcomes of patients with blood cancer in Australia and New Zealand.
Timepoint [4] 296578 0
mid 2012 onwards
Secondary outcome [5] 296579 0
To gain better understanding of disease progression and patterns of care for patients with blood cancers not participating in clinical trials.
Timepoint [5] 296579 0
mid 2012 onwards
Secondary outcome [6] 296580 0
To inform and facilitate design of future ALLG studies for patients with blood cancer.
Timepoint [6] 296580 0
mid 2012 onwards

Eligibility
Key inclusion criteria
1. Male or female with a suspected, or known, or diagnosed blood cancer
2. Aged 15 and over
3. Has provided written informed consent
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
21/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
4228
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 8531 0
The Alfred - Prahran
Recruitment hospital [2] 11347 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [3] 11348 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 11349 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 11350 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 11351 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 11352 0
The Canberra Hospital - Garran
Recruitment hospital [8] 11353 0
Concord Repatriation Hospital - Concord
Recruitment hospital [9] 11354 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 11355 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [11] 11356 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [12] 11357 0
Gosford Hospital - Gosford
Recruitment hospital [13] 11358 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 11359 0
Liverpool Hospital - Liverpool
Recruitment hospital [15] 11360 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [16] 11361 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [17] 11362 0
Nepean Hospital - Kingswood
Recruitment hospital [18] 11363 0
The Northern Hospital - Epping
Recruitment hospital [19] 11364 0
Orange Health Service - Orange
Recruitment hospital [20] 11365 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [21] 11366 0
Prince of Wales Hospital - Randwick
Recruitment hospital [22] 11367 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [23] 11368 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [24] 11369 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [25] 11370 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [26] 11371 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [27] 11372 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [28] 11373 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [29] 11374 0
St George Hospital - Kogarah
Recruitment hospital [30] 11375 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [31] 11376 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [32] 11377 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [33] 11378 0
The Townsville Hospital - Douglas
Recruitment hospital [34] 11379 0
Westmead Hospital - Westmead
Recruitment hospital [35] 11380 0
Wollongong Hospital - Wollongong
Recruitment hospital [36] 13980 0
Launceston General Hospital - Launceston
Recruitment hospital [37] 13981 0
Royal Perth Hospital - Perth
Recruitment hospital [38] 18083 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [39] 22203 0
Border Medical Oncology - Albury
Recruitment hospital [40] 22204 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [41] 24507 0
Gold Coast University Hospital - Southport
Recruitment hospital [42] 24508 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [43] 24509 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 16625 0
3004 - Prahran
Recruitment postcode(s) [2] 23246 0
3052 - Parkville
Recruitment postcode(s) [3] 23247 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [4] 23248 0
5000 - Adelaide
Recruitment postcode(s) [5] 23249 0
3084 - Heidelberg
Recruitment postcode(s) [6] 23250 0
2148 - Blacktown
Recruitment postcode(s) [7] 23251 0
3128 - Box Hill
Recruitment postcode(s) [8] 23252 0
2605 - Garran
Recruitment postcode(s) [9] 23253 0
2139 - Concord
Recruitment postcode(s) [10] 23254 0
5042 - Bedford Park
Recruitment postcode(s) [11] 23255 0
6150 - Murdoch
Recruitment postcode(s) [12] 23256 0
3220 - Geelong
Recruitment postcode(s) [13] 23257 0
2250 - Gosford
Recruitment postcode(s) [14] 23258 0
7000 - Hobart
Recruitment postcode(s) [15] 23259 0
2170 - Liverpool
Recruitment postcode(s) [16] 23260 0
2298 - Waratah
Recruitment postcode(s) [17] 23261 0
3168 - Clayton
Recruitment postcode(s) [18] 23262 0
2747 - Kingswood
Recruitment postcode(s) [19] 23263 0
3076 - Epping
Recruitment postcode(s) [20] 23264 0
2800 - Orange
Recruitment postcode(s) [21] 23265 0
4102 - Woolloongabba
Recruitment postcode(s) [22] 23266 0
2031 - Randwick
Recruitment postcode(s) [23] 23267 0
5011 - Woodville
Recruitment postcode(s) [24] 23268 0
4029 - Herston
Recruitment postcode(s) [25] 23269 0
0810 - Tiwi
Recruitment postcode(s) [26] 23270 0
2065 - St Leonards
Recruitment postcode(s) [27] 23271 0
4700 - Rockhampton
Recruitment postcode(s) [28] 23272 0
2050 - Camperdown
Recruitment postcode(s) [29] 23273 0
6009 - Nedlands
Recruitment postcode(s) [30] 23274 0
2217 - Kogarah
Recruitment postcode(s) [31] 23275 0
3065 - Fitzroy
Recruitment postcode(s) [32] 23276 0
2010 - Darlinghurst
Recruitment postcode(s) [33] 23277 0
4350 - Toowoomba
Recruitment postcode(s) [34] 23278 0
4814 - Douglas
Recruitment postcode(s) [35] 23279 0
2145 - Westmead
Recruitment postcode(s) [36] 23280 0
2500 - Wollongong
Recruitment postcode(s) [37] 26757 0
7250 - Launceston
Recruitment postcode(s) [38] 26758 0
6000 - Perth
Recruitment postcode(s) [39] 32071 0
2485 - Tweed Heads
Recruitment postcode(s) [40] 37361 0
2640 - Albury
Recruitment postcode(s) [41] 37362 0
4101 - South Brisbane
Recruitment postcode(s) [42] 40096 0
4215 - Southport
Recruitment postcode(s) [43] 40097 0
4575 - Birtinya
Recruitment postcode(s) [44] 40098 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 3902 0
New Zealand
State/province [1] 3902 0
Auckland, New Plymouth, Wellington, Nelson, Canterbury, Otago and Waikato

Funding & Sponsors
Funding source category [1] 284909 0
Other Collaborative groups
Name [1] 284909 0
Delaine Smith
Country [1] 284909 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Ground Floor, 35 Elizabeth St. Richmond, Vic, Australia, 3121
Country
Australia
Secondary sponsor category [1] 283785 0
None
Name [1] 283785 0
nil
Address [1] 283785 0
nil
Country [1] 283785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286907 0
Melbourne Health HREC
Ethics committee address [1] 286907 0
Ethics committee country [1] 286907 0
Australia
Date submitted for ethics approval [1] 286907 0
23/03/2012
Approval date [1] 286907 0
20/08/2012
Ethics approval number [1] 286907 0
Ethics committee name [2] 303578 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [2] 303578 0
Ethics committee country [2] 303578 0
Australia
Date submitted for ethics approval [2] 303578 0
23/05/2012
Approval date [2] 303578 0
02/08/2012
Ethics approval number [2] 303578 0
HREC/12/TQEHLMH/35
Ethics committee name [3] 303579 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [3] 303579 0
Ethics committee country [3] 303579 0
Australia
Date submitted for ethics approval [3] 303579 0
04/10/2012
Approval date [3] 303579 0
21/11/2012
Ethics approval number [3] 303579 0
H0012836
Ethics committee name [4] 315041 0
Alfred Hospital Ethics Committee
Ethics committee address [4] 315041 0
Ethics committee country [4] 315041 0
Australia
Date submitted for ethics approval [4] 315041 0
24/05/2012
Approval date [4] 315041 0
30/10/2012
Ethics approval number [4] 315041 0
181/12
Ethics committee name [5] 315042 0
ACT Health Human Research Ethics Committee
Ethics committee address [5] 315042 0
Ethics committee country [5] 315042 0
Australia
Date submitted for ethics approval [5] 315042 0
08/04/2013
Approval date [5] 315042 0
19/06/2013
Ethics approval number [5] 315042 0
ETH.3.13.049
Ethics committee name [6] 315043 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [6] 315043 0
Ethics committee country [6] 315043 0
Australia
Date submitted for ethics approval [6] 315043 0
11/04/2014
Approval date [6] 315043 0
07/08/2014
Ethics approval number [6] 315043 0
RGS0000001649
Ethics committee name [7] 315044 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [7] 315044 0
Ethics committee country [7] 315044 0
New Zealand
Date submitted for ethics approval [7] 315044 0
19/04/2021
Approval date [7] 315044 0
10/05/2021
Ethics approval number [7] 315044 0
21/NTB/115

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

Contacts
Principal investigator
Name 33241 0
Prof Andrew Wei
Address 33241 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000
Country 33241 0
Australia
Phone 33241 0
+61 3 8559 7262
Fax 33241 0
Email 33241 0
andrew.wei@petermac.org
Contact person for public queries
Name 16488 0
Delaine Smith
Address 16488 0
Australasian Leukaemia and Lymphoma Group. Ground Floor, 35 Elizabeth St. Richmond, Vic, Australia, 3121
Country 16488 0
Australia
Phone 16488 0
+61 3 8373 9701
Fax 16488 0
Email 16488 0
delaine.smith@allg.org.au
Contact person for scientific queries
Name 7416 0
Andrew Wei
Address 7416 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000
Country 7416 0
Australia
Phone 7416 0
+61 3 8559 5000
Fax 7416 0
Email 7416 0
andrew.wei@petermac.org

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
EmbaseLaboratory quality assessment of candidate gene panel testing for acute myeloid leukaemia: a joint ALLG / RCPAQAP initiative.2021https://dx.doi.org/10.1016/j.pathol.2020.08.019
Dimensions AIMulti-Cohort Transcriptomic Subtyping of B-Cell Acute Lymphoblastic Leukemia2022https://doi.org/10.3390/ijms23094574
N.B. These documents automatically identified may not have been verified by the study sponsor.