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Trial registered on ANZCTR


Registration number
ACTRN12617000050358
Ethics application status
Approved
Date submitted
5/01/2017
Date registered
11/01/2017
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian and New Zealand Lymphoma and Related Diseases Registry
Scientific title
Australian and New Zealand Lymphoma and Related Diseases Registry
Secondary ID [1] 290836 0
None
Universal Trial Number (UTN)
Trial acronym
LaRDR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 301512 0
Condition category
Condition code
Cancer 301224 301224 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 301225 301225 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 301226 301226 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Months
Description of intervention(s) / exposure
This is a patient Registry collecting information on patients with a new diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukaemia and related diseases. Information will be collected by review of medical records.
Intervention code [1] 296760 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300635 0
Survival which is assessed by review of hospital records.


Timepoint [1] 300635 0
two years
Primary outcome [2] 300636 0
Quality of life which is assessed using the EQ-5D-5L questionnaire
Timepoint [2] 300636 0
two years
Secondary outcome [1] 330466 0
Time to disease progression which is assessed by review of hospital records.
Timepoint [1] 330466 0
Two years

Eligibility
Key inclusion criteria
Patients with a new diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukaemia and related diseases. Diagnosis within 6 months prior to HREC approval at the site, in order to minimise retrospective data collection.
Age 18 years or older
Cause of death listed as lymphoma.
Minimum age
18 Years
Maximum age
No limit
Gender
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
Analysis plans will be reviewed by the Steering Committee and by a suitably qualified statistician prior to data from the LaRDR being analysed.
A detailed pre-determined statistical plan will be developed prior to planned analyses of registry data.

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,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 7190 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7191 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 7192 0
Concord Private Hospital - Concord
Recruitment hospital [4] 7198 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 7199 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 7200 0
The Canberra Hospital - Garran
Recruitment hospital [7] 9607 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [8] 9608 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [9] 15290 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [10] 15291 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 15292 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 15293 0
Gosford Hospital - Gosford
Recruitment hospital [13] 15294 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [14] 15295 0
Royal Hobart Hospital - Hobart
Recruitment hospital [15] 15296 0
The Alfred - Melbourne
Recruitment hospital [16] 15297 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [17] 15298 0
Box Hill Hospital - Box Hill
Recruitment hospital [18] 15299 0
Sunshine Hospital - St Albans
Recruitment hospital [19] 15300 0
Epworth Richmond - Richmond
Recruitment hospital [20] 15301 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 14953 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 14954 0
3168 - Clayton
Recruitment postcode(s) [3] 14955 0
2137 - Concord
Recruitment postcode(s) [4] 14961 0
3000 - Melbourne
Recruitment postcode(s) [5] 14962 0
3084 - Heidelberg
Recruitment postcode(s) [6] 14963 0
2605 - Garran
Recruitment postcode(s) [7] 18364 0
6150 - Murdoch
Recruitment postcode(s) [8] 18365 0
6009 - Nedlands
Recruitment postcode(s) [9] 28600 0
4350 - Toowoomba
Recruitment postcode(s) [10] 28601 0
4575 - Birtinya
Recruitment postcode(s) [11] 28602 0
4215 - Southport
Recruitment postcode(s) [12] 28603 0
2250 - Gosford
Recruitment postcode(s) [13] 28604 0
2010 - Darlinghurst
Recruitment postcode(s) [14] 28605 0
7000 - Hobart
Recruitment postcode(s) [15] 28606 0
3220 - Geelong
Recruitment postcode(s) [16] 28607 0
3128 - Box Hill
Recruitment postcode(s) [17] 28608 0
3021 - St Albans
Recruitment postcode(s) [18] 28609 0
3121 - Richmond
Recruitment postcode(s) [19] 28610 0
3350 - Ballarat Central
Recruitment outside Australia
Country [1] 8546 0
New Zealand
State/province [1] 8546 0
Auckland

Funding & Sponsors
Funding source category [1] 295258 0
Commercial sector/Industry
Name [1] 295258 0
Takeda Pharmaceuticals Australia Pty Ltd
Address [1] 295258 0
Ground Floor
2-4 Lyon Park Rd
MACQUARIE PARK NSW 2113
Country [1] 295258 0
Australia
Funding source category [2] 295259 0
Commercial sector/Industry
Name [2] 295259 0
Roche Products Pty Ltd
Address [2] 295259 0
4-10 Inman Road
Dee Why, NSW, 2099
Country [2] 295259 0
Australia
Funding source category [3] 295260 0
Commercial sector/Industry
Name [3] 295260 0
Celgene Pty Limited
Address [3] 295260 0
Level 7, 607 St Kilda Rd,
Melbourne VIC 3004
Country [3] 295260 0
Australia
Funding source category [4] 295261 0
Commercial sector/Industry
Name [4] 295261 0
Bristol-Myers Squibb Australia Pty Ltd
Address [4] 295261 0
Level 2,
4 Nexus Court
Mulgrave, Victoria, 3170
Country [4] 295261 0
Australia
Funding source category [5] 295262 0
Commercial sector/Industry
Name [5] 295262 0
Janssen-Cilag Pty Ltd
Address [5] 295262 0
1-5 Khartoum Road
Macquarie Park NSW 2113
Country [5] 295262 0
Australia
Funding source category [6] 295263 0
Commercial sector/Industry
Name [6] 295263 0
Novartis Pharmaceuticals Australia Pty Ltd
Address [6] 295263 0
54 Waterloo Road
Macquarie Park, NSW, 2113
Country [6] 295263 0
Australia
Funding source category [7] 298259 0
Commercial sector/Industry
Name [7] 298259 0
AbbVie
Address [7] 298259 0
Level 7
241 O’Riordan Street
MASCOT NSW 2020
Country [7] 298259 0
Australia
Funding source category [8] 304363 0
Commercial sector/Industry
Name [8] 304363 0
Janssen-Cilag
Address [8] 304363 0
66 Waterloo Rd, Macquarie Park NSW 2113
Country [8] 304363 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton, Victoria, 3800

Country
Australia
Secondary sponsor category [1] 294088 0
None
Name [1] 294088 0
Address [1] 294088 0
Country [1] 294088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296598 0
Monash Health HREC
Ethics committee address [1] 296598 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [1] 296598 0
Australia
Date submitted for ethics approval [1] 296598 0
05/05/2016
Approval date [1] 296598 0
01/07/2016
Ethics approval number [1] 296598 0
HREC/16/MonH/74

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 age 18 years or older, with a new diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukaemia and related diseases.

Study details
Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the LaRDR database using a web portal:
Demographic details
Health at diagnosis
Laboratory and imaging results at diagnosis
Therapy decisions, including pre-therapy benchmarking, chemotherapy, autologous and allogeneic stem cell transplantation, and maintenance and supportive therapies
Outcomes including (survival and QoL measures.

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 for lymphoid cancers and assist with evaluation of the translation of advances in therapies outside the setting of clinical trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71442 0
Prof Erica Wood
Address 71442 0
Monash University
Department of Epidemiology and Preventive Medicine
553 St Kilda Road
Melbourne VIC 3004
Country 71442 0
Australia
Phone 71442 0
+61 3 99030051
Fax 71442 0
Email 71442 0
erica.wood@monash.edu
Contact person for public queries
Name 71443 0
A/Prof Zoe McQuilten
Address 71443 0
Monash University
Department of Epidemiology and Preventive Medicine
553 St Kilda Road
Melbourne VIC 3004
Country 71443 0
Australia
Phone 71443 0
+61 3 99030379
Fax 71443 0
Email 71443 0
zoe.mcquilten@monash.edu
Contact person for scientific queries
Name 71444 0
A/Prof Zoe McQuilten
Address 71444 0
Monash University
Department of Epidemiology and Preventive Medicine
553 St Kilda Road
Melbourne VIC 3004
Country 71444 0
Australia
Phone 71444 0
+61 3 99030379
Fax 71444 0
Email 71444 0
zoe.mcquilten@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results