Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000008921
Ethics application status
Not yet submitted
Date submitted
21/12/2010
Date registered
5/01/2011
Date last updated
5/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of Transplanted Heart Rejection by Blood Cell Gene Expression: a Novel Concept of Personalized Approach to Heart Transplantation Management
Scientific title
Detection of Cardiac Allograft Rejection by Peripheral Blood Gene Expression in Paediatric Cardiac Transplant Patients
Secondary ID [1] 253321 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-cardiac transplantation allograft rejection management. (Determining the clinical validity of a novel method for early detection of transplant organ rejection). 258861 0
Condition category
Condition code
Cardiovascular 258999 258999 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will be performed on 10 consecutive children undergoing heart transplantation. The venous blood sample (5 ml each) will be taken immediately after induction of anaesthesia prior to heart transplantation and then immediately after induction of anaesthesia prior to each regular routine endomyocardial biopsy during 1st year after transplantation (9 biopsies). Thus, this equates to a total of 10 samples per patient. Change in blood genomic profile is compared longtitudinally and compared with standard heart biopsy assessment of potential markers for organ rejection.
Intervention code [1] 257777 0
Not applicable
Comparator / control treatment
Longitudinal approach: a baseline genomic profile of each patient will serve as its own unique control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259855 0
Longtitudinal changes in personalized gene expression pattern (Oligonucleotide Array changes) in peripheral blood with onset of rejection.
Timepoint [1] 259855 0
Baseline blood sample at heart transplantation, then at 4-6 week (approx monthly) endomyocardial biopsy during 1st year after transplantation (9 biopsies). (10 timepoint measures total).
Secondary outcome [1] 268719 0
Nil
Timepoint [1] 268719 0
Nil

Eligibility
Key inclusion criteria
10 consecutive children aged 5-18 years undergoing heart transplantation and follow up clinical management at the Royal Children's Hospital, Melbourne.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac transplantation under age 5 and non-cardiac transplantation.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258241 0
Government body
Name [1] 258241 0
National Health & Medical Research Council
Country [1] 258241 0
Australia
Primary sponsor type
Individual
Name
Professor Igor Konstantinov
Address
Department of Cardiac Surgery
Royal Children's Hospital
Flemington Road,
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 257411 0
None
Name [1] 257411 0
Address [1] 257411 0
Country [1] 257411 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260221 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 260221 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Ethics committee country [1] 260221 0
Australia
Date submitted for ethics approval [1] 260221 0
26/11/2010
Approval date [1] 260221 0
Ethics approval number [1] 260221 0
30200A

Summary
Brief summary
Rejection of a transplanted heart is a serious and often fatal complication following heart transplantation. Endomyocardial biopsy is the gold standard for diagnosing heart transplant rejection. Transplanted patients undergo 9
endomyocardial biopsies for routine surveillance in the first 12 months after transplant.
We know that immune cells in peripheral blood become activated during rejection. They change their gene expression and this can be detected by specific biochemical tests called microarrays. As such, it is our belief that rejection of a transplanted heart may be detected by taking a peripheral blood sample and looking at the gene expression of immune cells. The implication is that
transplant rejection may be detected by simply taking blood rather than performing an endomyocardial biospy. An endomyocardial biospy is an invasive procedure performed under general anaesthesia and is therefore stressful for
patients and patients' parents as well as placing a sizeable on the healthcare system.
Our project will involve taking a small 5ml venous blood sample from patients immediately prior to heart transplantation and all subsequent endomyocardial biopsies for routine surveillance. The blood samples will be taken after induction of general anaesthesia. We will then be able to compare each result of the microarray of the blood sample with the result of the endomyocardial biopsy in order to assess whether peripheral blood sampling is a possible alternative to endomyocardial biospy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32036 0
Address 32036 0
Country 32036 0
Phone 32036 0
Fax 32036 0
Email 32036 0
Contact person for public queries
Name 15283 0
Professor Igor Konstantinov
Address 15283 0
Department of Cardiac Surgery
Royal Children's Hospital
Flemington Road,
Parkville VIC 3052
Country 15283 0
Australia
Phone 15283 0
+61 3 9345 5200
Fax 15283 0
+61 3 9345 6386
Email 15283 0
[email protected]
Contact person for scientific queries
Name 6211 0
Professor Igor Konstantinov
Address 6211 0
Department of Cardiac Surgery
Royal Children's Hospital
Flemington Road,
Parkville VIC 3052
Country 6211 0
Australia
Phone 6211 0
+61 3 9345 5200
Fax 6211 0
+61 3 9345 6386
Email 6211 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
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