Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000993998
Ethics application status
Not yet submitted
Date submitted
12/09/2011
Date registered
19/09/2011
Date last updated
19/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of Giant Cell Tumour of bone
Scientific title
Investigation of the cellular pathology underlying giant cell tumour (GCT) of bone to gain a deeper understanding of the processes leading to the generation of GCT and to determine the origin and role of the stromal cells present in the GCT.
Secondary ID [1] 263030 0
Nil
Universal Trial Number (UTN)
U1111-1124-5040
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant cell tumour (GCT) of bone 270757 0
Condition category
Condition code
Cancer 270937 270937 0 0
Bone

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a molecular mechanistic study. Excess giant cell tumour (GCT) tissue, obtained by surgical removal of the tumour from patients, will to be used for research purposes. The trial is expected to run for up to ten years, but will cease when adequate numbers have been recruited.

We aim to investigate what cells constitute the stromal component of GCT, how do the osteoclastic cells alter the functional activity of the stromal cells, and what impact does this have on our understanding of the link between bone formation and bone resorption in normal bone homeostasis.

Fresh tissue samples will be used for several purposes:

1) to isolate the giant cells (osteoclasts) and the stromal cell component of the tumour and culture these cells in vitro to investigate the cellular biology of GCT;
2) embedded tissue will be cut to enable immunohistochemical and histological examination of the tumour;
3) GCT samples will be snap frozen and processed for investigation of the gene expression patterns within the tumour.
Intervention code [1] 269371 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279602 0
What cells constitute the stromal component of GCT

Embedded tissue will be cut to enable immunohistochemical and histological examination of the tumour
Timepoint [1] 279602 0
Post surgical resection of GCT
Primary outcome [2] 279603 0
How do osteoclastic cells alter the functional activity of the stromal cells

Giant cells (osteoclasts) and the stromal cell component of the tumour will be isolated and cultured in vitro to investigate the cellular biology of GCT;
Furthermore GCT samples will be snap frozen and processed for investigation of the gene expression patterns within the tumour.
Timepoint [2] 279603 0
Post surgical resection of GCT
Secondary outcome [1] 294014 0
Nil
Timepoint [1] 294014 0
Nil

Eligibility
Key inclusion criteria
Patients who are undergoing surgery for removal or biopsy of GCT of bone
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outside age range
Other pathological diagnosis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269831 0
Hospital
Name [1] 269831 0
Orthopaedic Dept, Sir Charles Gairdner Hospital, Perth, WA
Country [1] 269831 0
Australia
Primary sponsor type
Hospital
Name
Orthopaedic Dept, Sir Charles Gairdner Hospital, Perth, WA
Address
Sir Charles Gairdner Hospital
Nedlands
Perth
WA 6009
Country
Australia
Secondary sponsor category [1] 268863 0
None
Name [1] 268863 0
Address [1] 268863 0
Country [1] 268863 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271798 0
Ethics committee address [1] 271798 0
Ethics committee country [1] 271798 0
Date submitted for ethics approval [1] 271798 0
20/09/2011
Approval date [1] 271798 0
Ethics approval number [1] 271798 0
2011-139

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

Contacts
Principal investigator
Name 33147 0
Address 33147 0
Country 33147 0
Phone 33147 0
Fax 33147 0
Email 33147 0
Contact person for public queries
Name 16394 0
Assoc Professor Richard Carey-Smith
Address 16394 0
Charles Gairdner Hospital
Nedlands
Perth
WA 6009
Country 16394 0
Australia
Phone 16394 0
+61 8 93461499
Fax 16394 0
Email 16394 0
[email protected]
Contact person for scientific queries
Name 7322 0
Assoc Professor Richard Carey-Smith
Address 7322 0
Sir Charles Gairdner Hospital
Nedlands
Perth
WA 6009
Country 7322 0
Australia
Phone 7322 0
+61 8 93461499
Fax 7322 0
Email 7322 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.