Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000963729
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
29/08/2013
Date last updated
19/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidemiology of Wegeners Granulomatosis
Scientific title
Epidemiology of Wegeners Granulomatosis: Identifying Risk Factors of Wegeners Granulomatosis
Secondary ID [1] 283041 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wegener's Granulomatosis 289876 0
Condition category
Condition code
Inflammatory and Immune System 290239 290239 0 0
Autoimmune diseases
Public Health 290266 290266 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Wegener's granulomatosis is an inflammatory disorder of the blood vessels. The cause of this condition is unknown. However, involvement of the upper airways and lungs suggests inhaled substances may have a role.
All cases and controls will undergo a detailed standarised interview regarding environmental exposures prior to the onset of the Wegeners (Cases) or at a matched time point for the controls. The interview will be done once only and will take 1 hour
Intervention code [1] 287761 0
Not applicable
Comparator / control treatment
Nil - observational
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290260 0
Risk factors for disease will be identifed from the exposures determined in the questionnaire
Timepoint [1] 290260 0
Time of disease onset
Secondary outcome [1] 304219 0
nil
Timepoint [1] 304219 0
nil

Eligibility
Key inclusion criteria
Cases: Wegeners granulomatosis
Controls osteoarthritis or asthma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
Comparisons for historical exposures that may relate to disease onset will be compared between cases and controls

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2010
Actual
20/09/2010
Date of last participant enrolment
Anticipated
28/02/2012
Actual
28/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
245
Recruitment outside Australia
Country [1] 5319 0
New Zealand
State/province [1] 5319 0
Canterbury

Funding & Sponsors
Funding source category [1] 287807 0
Self funded/Unfunded
Name [1] 287807 0
Country [1] 287807 0
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
P.O. Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 286534 0
None
Name [1] 286534 0
Address [1] 286534 0
Country [1] 286534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289756 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 289756 0
Ministry of Health
P.O.Box 3877
Christchurch 8011
Ethics committee country [1] 289756 0
New Zealand
Date submitted for ethics approval [1] 289756 0
Approval date [1] 289756 0
07/07/2010
Ethics approval number [1] 289756 0
URB/10/06/021

Summary
Brief summary
Wegener’s Granulomatosis (WG) and WG-like diseases affect the small/medium sized blood vessels. In Canterbury the prevalence of WG is one of the highest in the world. Despite this, we are reliant on information from the Northern Hemisphere to guide us on causes, outcomes and treatments. While the causes of WG are unknown the typical involvement of the respiratory tract suggests that inhaled agents may trigger the disease. Although no definite environmental factor has been identified, a number of potential agents have been suggested by previous studies. In a large English case-controlled study farming, solvent exposure and allergy were found to be associated with WG. Another study identified mercury and possibly lead exposure as having a potential in the development of WG. More recently a strong relationship between the incidence of WG and ambient UV radiation. Thus there is growing evidence that environmental factors have a role in the aetiology of WG. We wish to determine whether there are potential environmental factors related to the onset of WG in Canterbury New Zealand and compare our findings to those in England.
Trial website
Trial related presentations / publications
Stamp LK, Chapman PT, Francis J, Beckert L, Frampton C, Watts R and O’Donnell JL. Association between environmental exposures and granulomatosis with polyangiitis in Canterbury, New Zealand. Arthritis Res Ther 2015; 17:333 DOI 10.1186/s13075-015-0852-6
Public notes

Contacts
Principal investigator
Name 42222 0
Prof Lisa Stamp
Address 42222 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42222 0
New Zealand
Phone 42222 0
+6433640953
Fax 42222 0
Email 42222 0
lisa.stamp@cdhb.govt.nz
Contact person for public queries
Name 42223 0
Ms Janine Franics
Address 42223 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42223 0
New Zealand
Phone 42223 0
+6433686487
Fax 42223 0
Email 42223 0
janine.francis@cdhb.govt.nz
Contact person for scientific queries
Name 42224 0
Prof Lisa Stamp
Address 42224 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 42224 0
New Zealand
Phone 42224 0
+6433640953
Fax 42224 0
Email 42224 0
lisa.stamp@cdhb.govt.nz

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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