Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609001009202
Ethics application status
Approved
Date submitted
19/11/2009
Date registered
23/11/2009
Date last updated
23/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess the expression of kallikreins, kininogens and kinin receptors in circulating and synovial fluid neutrophils in gout.
Scientific title
Pilot study to assess the expression of kallikreins, kininogens and kinin receptors in circulating and synovial fluid neutrophils in gout
Secondary ID [1] 1139 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 252243 0
Condition category
Condition code
Musculoskeletal 252429 252429 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients from Royal Perth hospital with gout of the knee will be asked to have some blood tests, an ultrasound examination of their knee and fluid withdrawn from the knee to look for evidence of kallikren kinin proteins involved in inflammation. The study is an observational cross sectional study observing disease activity ( as assessed by symptoms and ultrasound) and kinin metabolism at one time point, although recruitment is likely to take 12 months; nil intervention
Intervention code [1] 241576 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253306 0
To determine by light and confocal immunocytochemistry, the expression of kallikreins, kininogens, and kinin receptors on neutrophils harvested from the circulation and synoival fluid of patients with gout.
Timepoint [1] 253306 0
cross sectional
Secondary outcome [1] 262349 0
To determine whether expression of kallikreins, kininogens, and kinin receptors on neutrophils harvested from synovial fluid correlates with joint disease in patients with gout.
Timepoint [1] 262349 0
cross sectional
Secondary outcome [2] 262350 0
To determine if expression and localization of kallikreins, kininogens, and kinin receptors in patients with gout correlates with joint disease in patients with gout.
Timepoint [2] 262350 0
cross sectional

Eligibility
Key inclusion criteria
*Gout of the knee
*Aged more than 18 years
*Able to provide written informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Contraindication or unwillingness to undergo an Ultrasound scan
*Contraindication or unwillingness to undergo arthrocentesis (including an International normalised ratio greater than 2.0 in subjects on warfarin, or patients on therapeutic dose heparin/ Low molecular weight heparin)
*Diagnosis of septic arthritis, other inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondrosis
*injury to the study knee within 6 months of the study start
*knee joint replacement (partial or total); osteotomy of the studied joint; with arthroscopy of the studied joint made within 1 year of the study start
*With an intra articular injection of steroids made within 4 weeks and/or intra articular injection of radionuclide made with 3 months prior to study entry

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
22/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244054 0
University
Name [1] 244054 0
University of Western Asutralia
Country [1] 244054 0
Australia
Funding source category [2] 244058 0
University
Name [2] 244058 0
University of Western Australia
Country [2] 244058 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington St
Perth 6000
Western Australia
Country
Australia
Secondary sponsor category [1] 251401 0
None
Name [1] 251401 0
Address [1] 251401 0
Country [1] 251401 0
Other collaborator category [1] 966 0
Other
Name [1] 966 0
Kanti Bhoola
Address [1] 966 0
Lung Institue of Western Australia
Ground Floor E Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands Western Australia 6006
Country [1] 966 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258150 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 258150 0
Room 5105 Level 5, Colonial House
Royal Perth Hospital
Wellington St
Perth 6000
Western Australia
Ethics committee country [1] 258150 0
Australia
Date submitted for ethics approval [1] 258150 0
05/10/2010
Approval date [1] 258150 0
Ethics approval number [1] 258150 0
EC 2009/111

Summary
Brief summary
Patients from Royal Perth hospital with gout of the knee will be asked to have some blood tests, an ultrasound examination of their knee and fluid withdrawn from the knee to look for evidence of kallikren kinin proteins involved in inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30530 0
Address 30530 0
Country 30530 0
Phone 30530 0
Fax 30530 0
Email 30530 0
Contact person for public queries
Name 13777 0
Helen Keen
Address 13777 0
Level 3 MRF Buidling
Rear 50 Murray St
Perth 6000
Western Australia
Country 13777 0
Australia
Phone 13777 0
+61 8 9224 2244
Fax 13777 0
Email 13777 0
[email protected]
Contact person for scientific queries
Name 4705 0
Helen Keen
Address 4705 0
Level 3 MRF Buidling
Rear 50 Murray St
Perth 6000
Western Australia
Country 4705 0
Australia
Phone 4705 0
+61 8 9224 2244
Fax 4705 0
Email 4705 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.