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Trial registered on ANZCTR
Registration number
ACTRN12605000156684
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
15/08/2005
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Fungal allergy and domestic exposure to fungi in cystic fibrosis (Australian Cystic Fibrosis Research Trust 2004/052)
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Scientific title
Fungal exposure and fungal-specific lgE in subjects with cystic fibrosis (Australian Cystic Fibrosis Research Trust 2004/052)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Allergic Bronchopulmonary Aspergillosis
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Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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Cystic fibrosis
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Blood
282
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
No interventions. This is an observational study. We will observe:
Participant's exposure and allergic reaction to environmental fungi. No drugs or treatments will be administered.
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Intervention code [1]
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None
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The identity of fungal allergens to which participants are exposed and the associated allergic response will be investigated.
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Assessment method [1]
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Timepoint [1]
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One measurement will be made per participant over 24 hours.
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Secondary outcome [1]
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Mechanisms of allergen release from fungal spores.
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Assessment method [1]
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Timepoint [1]
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These will be in-vitro measurements.
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Eligibility
Key inclusion criteria
Fungal allergic cystic fibrosis patients. CF patients with ABPA
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2004
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Actual
1/03/2004
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Date of last participant enrolment
Anticipated
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Actual
31/12/2004
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Date of last data collection
Anticipated
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Actual
31/12/2004
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian Cystic Fibrosis Research Trust
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Australian Cystic Fibrosis Research Trust 2004/052
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Address
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Country
Australia
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Secondary sponsor category [1]
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Other
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Name [1]
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N/A
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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01/03/2004
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Ethics approval number [1]
1280
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Ethics committee name [2]
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The Central Sydney Area Health Service Ethics Review Committee
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Ethics committee address [2]
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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Ethics approval number [2]
1281
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Ethics committee name [3]
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The Children's Hospital at Westmead Ethics Review Committee
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Ethics committee address [3]
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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Approval date [3]
1282
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Ethics approval number [3]
1282
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
Details not known
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ms Wendy Taylor
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Address
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PO Box M77
Missenden Road
Camperdown NSW 2050
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Country
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Australia
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Phone
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+61 2 95156578
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Fax
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+61 2 95505865
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Euan Tovey
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Address
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University of Sydney
Room 461
Blackburn Building D06
Camperdown NSW 2006
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Country
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Australia
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Phone
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+61 2 93512093
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Fax
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+61 2 93517451
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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