Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001094763
Ethics application status
Approved
Date submitted
19/08/2013
Date registered
30/09/2013
Date last updated
30/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Risk Factors and Response to Therapy in Heart and Lung Transplant Patients with Posttransplant Lymphoproliferative Disease
Scientific title
Risk Factors and Response to Therapy in Heart and Lung Transplant Patients with Posttransplant Lymphoproliferative Disease
Secondary ID [1] 283033 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttransplant Lymphoproliferative Disease 289867 0
Condition category
Condition code
Cancer 290227 290227 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study looking at factors which contribute to the risk of developing Post-transplant Lymphoproliferative Disease (PTLD) in heart and lung transplant patients as well as looking at what treatment was recieved and how this correlates to outcomes. Participants will be observed in a retrospective fashion from the time of diagnosis of PTLD until present
Intervention code [1] 287753 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290248 0
Survival
Timepoint [1] 290248 0
Retrospective data collected from January 1984- January 2013
Secondary outcome [1] 304202 0
Relapse- Assessed by collection of data from patient records and haematology/transplant databases
Timepoint [1] 304202 0
Retrospective data collected from January 1984- January 2013
Secondary outcome [2] 304335 0
Complications of treatment- Eg infection, mucositis, renal and hepatic toxicity. These measures are all assessed by collection of documented data from patient notes and from existing databases.
Timepoint [2] 304335 0
Retrospective data collected from January 1984-January 2013
Secondary outcome [3] 304336 0
Transplant rejection episodes- Assessed by documented evidence of rejection from patient notes and existing databases
Timepoint [3] 304336 0
Retrospective data collected from January 1984-January 2013

Eligibility
Key inclusion criteria
Heart and Lung transplant patients who were transplanted at St Vincent's Hospital, Sydney from the commencement of the transplant program until 2013.
Posttransplant lymphoproliferative disease was an inclusion criteria. No other malignant diseases were elligible.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Univariate and multivariate analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
1/08/2012
Date of last participant enrolment
Anticipated
12/08/2013
Actual
12/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1444 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 287795 0
Self funded/Unfunded
Name [1] 287795 0
No funding
Country [1] 287795 0
Primary sponsor type
Individual
Name
John Moore
Address
C/- Kinghorn Cancer Centre
Department of Haematology
Victoria Street
Darlinghurst 2010 NSW
Country
Australia
Secondary sponsor category [1] 286525 0
None
Name [1] 286525 0
N/A
Address [1] 286525 0
N/A
Country [1] 286525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289744 0
St Vincent's
Ethics committee address [1] 289744 0
Ethics committee country [1] 289744 0
Australia
Date submitted for ethics approval [1] 289744 0
Approval date [1] 289744 0
Ethics approval number [1] 289744 0

Summary
Brief summary
This paper reports on the post-transplant lymphoproliferative disease (PTLD) experience of a single centre heart and lung transplant unit from its inception in 1984 to 2011 with respect to patient demographics, risk factors, management and outcomes. This detailed retrospective analysis aims to identify risk factors and describe outcomes in heart and lung transplant patients with PTLD to understand the unique clinical features of their disease in order to further develop tailored treatment strategies and prophylaxis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42210 0
Dr Orly Lavee
Address 42210 0
c/- Sydney Children's Hospital
Kids Cancer Centre
High Street
Randwick 2031 NSW
Country 42210 0
Australia
Phone 42210 0
+61 (0)407906902
Fax 42210 0
Email 42210 0
[email protected]
Contact person for public queries
Name 42211 0
Dr Orly Lavee
Address 42211 0
c/- Sydney Children's Hospital
Kids Cancer Centre
High Street
Randwick 2031 NSW
Country 42211 0
Australia
Phone 42211 0
+61 (0)407906902
Fax 42211 0
Email 42211 0
[email protected]
Contact person for scientific queries
Name 42212 0
Dr Orly Lavee
Address 42212 0
c/- Sydney Children's Hospital
Kids Cancer Centre
High Street
Randwick 2031 NSW
Country 42212 0
Australia
Phone 42212 0
+61 (0)407906902
Fax 42212 0
Email 42212 0
[email protected]

No information has been provided regarding IPD availability


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.