Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000514707
Ethics application status
Approved
Date submitted
26/02/2022
Date registered
31/03/2022
Date last updated
31/03/2022
Date data sharing statement initially provided
31/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical phenotypes and incidence of Anti-Neutrophilic Cytoplasmic Autoantibodies (ANCA) positive renal vasculitis in Queensland: The effect of environmental and occupational exposure
Scientific title
Clinical phenotypes and incidence of Anti-Neutrophilic Cytoplasmic Autoantibodies (ANCA) positive renal vasculitis in Queensland: The effect of environmental and occupational exposure
Secondary ID [1] 306449 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anti-Neutrophil Cytoplasmic Antibodies (ANCA) vasculitis 325288 0
Renal Vasculitis 325289 0
Condition category
Condition code
Renal and Urogenital 322687 322687 0 0
Kidney disease
Inflammatory and Immune System 322688 322688 0 0
Autoimmune diseases
Public Health 323054 323054 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adults who had a renal biopsy confirmed ANCA vasculitis will be invited to participate.
Participants will have their data collected via questionaires, data collection from patient contact will include their past occupational history, environmental exposure to hazards including silica, dust, fumes, pesticides... There are no intervention planned in this study. Participants are required to complete questionnaires at enrolment only.
Other data collected are from patient's medical records, including historic blood serological results, basic demographics, past treatment received and clinical response. Data will be collected via accessing in hopsital paper medical charts, Integrated Electronic Medical Records (ieMR) and Pathology Queensland database (AusLab/AusCare). These data are collected retrospectively covering study period of 2005-2021 and does not require any patient contact.
Intervention code [1] 322880 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330484 0
Primary outcome is to determine epidemiology/ case burden of ANCA renal vasculitis in Queensland as determined by renal biopsy data from Pathology Queensland
Timepoint [1] 330484 0
November 2021 - The end of this retrospective study time frame
Primary outcome [2] 330818 0
To examine occupational and environmental risk/exposures of patients with ANCA vasculitis.
Timepoint [2] 330818 0
November 2021 - The end of this retrospective study time frame
Secondary outcome [1] 406394 0
Examine the rate of malignancy complication in patients with ANCA renal vasculitis, this is determined by data-linkage to medical records and crossed checked with patient questionnaire designed specifically for this study.
Timepoint [1] 406394 0
November 2021 - The end of this retrospective study time frame
Secondary outcome [2] 407694 0
Examine the rate of venous thromboembolism complication in patients with ANCA renal vasculitis, this is determined by data-linkage to medical records and crossed checked with patient questionnaire designed specifically for this study.
Timepoint [2] 407694 0
November 2021 - The end of this retrospective study time frame
Secondary outcome [3] 407695 0
Examine the rate of cardiovascular disease complication in patients with ANCA renal vasculitis, this is determined by data-linkage to medical records and crossed checked with patient questionnaire designed specifically for this study.
Timepoint [3] 407695 0
November 2021 - The end of this retrospective study time frame

Eligibility
Key inclusion criteria
Adult patients whom had renal biopsy confirmed pauci-immune glomerulonephritis between 2005-2021
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
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/04/2022
Actual
Date of last participant enrolment
Anticipated
26/09/2022
Actual
Date of last data collection
Anticipated
26/09/2022
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21753 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 21754 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [3] 21755 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [4] 21756 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 36807 0
4029 - Herston
Recruitment postcode(s) [2] 36809 0
4350 - Toowoomba
Recruitment postcode(s) [3] 36808 0
4700 - Rockhampton
Recruitment postcode(s) [4] 36810 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 310799 0
University
Name [1] 310799 0
Griffith University
Country [1] 310799 0
Australia
Primary sponsor type
Individual
Name
Dr Ken Chau
Address
Department of Renal Medicine,
Royal Brisbane and Women's Hospital
Butterfield St,
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 312043 0
Individual
Name [1] 312043 0
Dwarakanathan Ranganathan
Address [1] 312043 0
Department of Renal Medicine,
Royal Brisbane and Women's Hospital
Butterfield St,
Herston
QLD 4029
Country [1] 312043 0
Australia
Other collaborator category [1] 282163 0
Hospital
Name [1] 282163 0
Toowoomba Hospital
Address [1] 282163 0
Pechey St,
Toowoomba City
QLD 4350
Country [1] 282163 0
Australia
Other collaborator category [2] 282164 0
Hospital
Name [2] 282164 0
Rockhampton Hospital
Address [2] 282164 0
2 Canning St,
Rockhampton
QLD 4700
Country [2] 282164 0
Australia
Other collaborator category [3] 282165 0
Hospital
Name [3] 282165 0
Mackay Hospital
Address [3] 282165 0
475 Bridge Rd,
Mackay
QLD 4740
Country [3] 282165 0
Australia
Other collaborator category [4] 282166 0
Hospital
Name [4] 282166 0
Royal Brisbane and Women's Hospital
Address [4] 282166 0
Butterfield St,
Herston
QLD 4029
Country [4] 282166 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310367 0
RBWH Human Research Ethics Committee
Ethics committee address [1] 310367 0
Level 2, Building 34
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston Qld 4029
Australia
Ethics committee country [1] 310367 0
Australia
Date submitted for ethics approval [1] 310367 0
Approval date [1] 310367 0
21/09/2021
Ethics approval number [1] 310367 0

Summary
Brief summary
This is a retrospective multi-centre observational study that aims to determine the effect of environmental and occupational exposures on clinical phenotypes and incidences of ANCA positive renal vasculitis in Queensland.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117406 0
A/Prof Dwarakanathan Ranganathan
Address 117406 0
Department of Renal Medicine,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston
QLD 4029
Country 117406 0
Australia
Phone 117406 0
+61736468576
Fax 117406 0
Email 117406 0
dwarakanathan.ranganathan@health.qld.gov.au
Contact person for public queries
Name 117407 0
Dr Ken Chau
Address 117407 0
Department of Renal Medicine,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston
QLD 4029
Country 117407 0
Australia
Phone 117407 0
+61736468111
Fax 117407 0
Email 117407 0
ken.chau@health.qld.gov.au
Contact person for scientific queries
Name 117408 0
Dr Ken Chau
Address 117408 0
Department of Renal Medicine,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston
QLD 4029
Country 117408 0
Australia
Phone 117408 0
+61736468111
Fax 117408 0
Email 117408 0
ken.chau@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval does not allow sharing of individual participant data. Data presented must not be identifiable to the individual.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15111Study protocol    383587-(Uploaded-27-03-2022-23-23-04)-Study-related document.doc
15113Ethical approval    383587-(Uploaded-16-02-2022-00-07-22)-Study-related document.pdf



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.