Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000792628
Ethics application status
Approved
Date submitted
28/04/2014
Date registered
25/07/2014
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cell and Molecular Biology of Vascular Anomalies
Scientific title
The effect of biologically significant pathways (such as the Renin-angiotensin system) on biological processes including haematopoiesis, in the regulation of vascular anomalies in a population of both adult and paediatric patients with vascular anomalies.
Secondary ID [1] 283362 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Anomalies 290260 0
Condition category
Condition code
Skin 290650 290650 0 0
Other skin conditions
Cardiovascular 292794 292794 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The programmed biologic behaviour (ie. rapid growth and slow but inevitable regression involution) of infantile
haemangiomas is precisely controlled by the interaction between cells and their niche. We intend to use freshly
excised and frozen, and parrafin fixed vascular anomaly tissues to further investigate the cellular mechanisms
leading to these lesions. We are also looking for further evidence to substantiate our recent published findings on
biologically significant pathways, such as the effect of hormonal systems including the renin-angiotensin
system on biological processes including haematopoiesis, in the regulation of these vascular anomalies.
The patients in this study after signing a consent form, have their vascular anomaly tissue excised under general anesthetic. It is then entered into our onsite tissue bank - in either snap frozen or paraffin blocked form. As hypothesis surrounding the mechanisms and biology of vascular anomalies are postulated, tissue is taken from the tissue bank for analysis. The is a broad ranging study and is ongoing, and has an ethics approved end date of 01.01.2023
Intervention code [1] 288087 0
Not applicable
Comparator / control treatment
There is not control group as we are looking at excised tissues. Our control tissue however is Placenta.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290666 0
Freshly removed tissue samples will be cultured using methods previously used by our laboratory to obtain cells which will be;
1. Characterised using standard immunocytochemistry,
real time PCR, and western blot.
Timepoint [1] 290666 0
Ongoing, the tissue samples will be obtained on a single occasion for most participants, however for participants who have a revision of their vascular anomaly at any point in time, a second sample will be collected, and the patients will be re-consented at each occasion.
Primary outcome [2] 292646 0
2. Grown in conditioned growth media using cytokines to determine their effect on cellular differentiation.
Timepoint [2] 292646 0
Ongoing, the tissue samples will be obtained on a single occasion for most participants, however for participants who have a revision of their vascular anomaly at any point in time, a second sample will be collected, and the patients will be re-consented at each occasion.
Primary outcome [3] 292647 0
3.Propagated and investigated for their ability to ‘reform ‘these lesions.
Timepoint [3] 292647 0
Ongoing, the tissue samples will be obtained on a single occasion for most participants, however for participants who have a revision of their vascular anomaly at any point in time, a second sample will be collected, and the patients will be re-consented at each occasion.
Secondary outcome [1] 304995 0
Identification of the key cellular components and their spatial and temporal expression patterns will be studied using paraffin embedded tissues by applying techniques such as immuno-histochemistry.
Timepoint [1] 304995 0
Ongoing - an anticipated end time-point as stated on our ethics application is 10 years - 2023. We endeavor to publish information as it comes to light regularly throughout this time.

Eligibility
Key inclusion criteria
Any patient undergoing surgical excision of a vascular anomaly who and/or their caregiver/parents give consent for the specimen to be stored in the tissue bank and used for research. Lesions including vascular tumours (such as
haemangioma) and vascular malformations including capillary, venous and lymphatic.
Minimum age
0 Months
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient/caregiver who does not wish to give consent for their specimen to be used for research, and any
specimen that is deemed inappropriate (too small) for research by the pathologist receiving that specimen.
If a patient consents to donate their tissue to the tissue bank, but declines to donate the requested serum and/or
urine samples, their tissue will still be added to the tissue bank as per their consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This study was entered in error it is not a clinical trial
Date of first participant enrolment
Anticipated
1/05/2014
Actual
Date of last participant enrolment
Anticipated
7/10/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 5485 0
New Zealand
State/province [1] 5485 0

Funding & Sponsors
Funding source category [1] 288090 0
Charities/Societies/Foundations
Name [1] 288090 0
Gillies McIndoe Research Institute
Country [1] 288090 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Gillies McIndoe Research Institute
Address
PO Box 7184
Newtown
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 286812 0
None
Name [1] 286812 0
Address [1] 286812 0
Country [1] 286812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290015 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290015 0
PO Box 5013
Wellington, 6145
Ethics committee country [1] 290015 0
New Zealand
Date submitted for ethics approval [1] 290015 0
10/09/2013
Approval date [1] 290015 0
02/10/2013
Ethics approval number [1] 290015 0
13/CEN/130

Summary
Brief summary
We will use frozen and formalin fixed tissues from our tissue bank, freshly excised surgical specimens and up to 10mls of patient serum and urine from both patients treated surgically and medically, to investigate the cause of vascular anomalies including vascular tumours (such as infantile haemangioma) and vascular malformations including arterial, venous, lymphatic malformation and arteriovenous malformations. Recent research by our group has found the involvement of stem cells and the Renin Angiotensin system (RAS) in the regulation of infantile haemangioma proliferation and involution. We seek to continue to explore the cellular and biological pathways that govern the growth of these vascular tumours and apply our knowledge in the investigation of other vascular anomalies, including expression of haematopoietic, vascular
endothelial growth factor and the RAS pathways.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43486 0
Dr Swee T Tan
Address 43486 0
Gillies McIndoe Research Institute
PO Box 7184
Newtown,
Wellington 6242
Country 43486 0
New Zealand
Phone 43486 0
64 4 2820366
Fax 43486 0
Email 43486 0
[email protected]
Contact person for public queries
Name 43487 0
Dr Swee T Tan
Address 43487 0
C/o Gillies McIndoe Research Institute
PO Box 7184, Newtown
Wellington South 6242,
New Zealand
Country 43487 0
New Zealand
Phone 43487 0
64 4 2820366
Fax 43487 0
Email 43487 0
[email protected]
Contact person for scientific queries
Name 43488 0
Dr Swee T Tan
Address 43488 0
C/o Gillies McIndoe Research Institute
PO Box 7184, Newtown
Wellington South 6242,
New Zealand
Country 43488 0
New Zealand
Phone 43488 0
64 4 2820366
Fax 43488 0
Email 43488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial withdrawn


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.