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Trial registered on ANZCTR
Registration number
ACTRN12611000877987
Ethics application status
Not yet submitted
Date submitted
15/08/2011
Date registered
17/08/2011
Date last updated
17/08/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Mannose-binding lectin (MBL) deficiency is more frequent in rheumatoid arthritis patients with coexistant bronchiectasis than in patients with rheumatoid arthritis alone or bronchiectasis alone.
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Scientific title
Are patients who have co-existant Rheumatoid arthritis and bronchiectasis more likely to be deficient in mannose-binding lectin (MBL) compared with patients with rheumatoid arthritis alone or bronchiectasis alone?
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Secondary ID [1]
262834
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Nil
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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:
Rheumatoid arthritis
270559
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Bronchiectasis
270560
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Condition category
Condition code
Inflammatory and Immune System
270721
270721
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0
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Rheumatoid arthritis
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Respiratory
270722
270722
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0
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Other respiratory disorders / diseases
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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
With the permission of the heads of department of both Rheumatology and Respiratory medicine at Fremantle Hospital, an audit will take place of patients attending the outpatient clinic of both of these departments between 2006 and 2010. At the same time an audit of patients attending the private rooms of one of the investigators will also be carried out. This audit will identify subjects who have had a serum MBL level measured at some part of their disease investigation and who have a diagnosis of rheumatoid arthritis alone, bronchiectasis alone, or coexisting RA and bronchiectasis. Once the patients have been identified, data including age, sex and details of diagnosis will be collated from the existing patient record. The audit and data collection will take place over a 3 month period commencing September 2011.
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Intervention code [1]
269187
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Not applicable
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Comparator / control treatment
Serum MBL levels of subjects suffering both RA and Bronchiectasis will be compared with serum MBL levels of subjects suffering RA alone and subjects suffering bronchiectasis alone.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Frequency of MBL deficiency in identified subjects.
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Assessment method [1]
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Timepoint [1]
269429
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End of study period
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Secondary outcome [1]
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nil
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Assessment method [1]
287622
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Timepoint [1]
287622
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nil
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Eligibility
Key inclusion criteria
Diagnosis of RA according to American College of Rheumatology criteria.
Diagnosis of Bronchiectasis made by a Consultant Respiratory physician
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Minimum age
No limit
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Maximum age
No limit
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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
Nil
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
269658
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Self funded/Unfunded
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Name [1]
269658
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N/A
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Address [1]
269658
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N/A
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Country [1]
269658
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Australia
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Primary sponsor type
Individual
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Name
Krista Makin
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Address
Fremantle Hospital
Alma St
Fremantle WA 6160
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Country
Australia
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Secondary sponsor category [1]
266696
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Individual
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Name [1]
266696
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Dr Graeme Carroll
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Address [1]
266696
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Fremantle Hospital Alma St Fremantle WA 6160
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Country [1]
266696
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
269606
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South Metropolitan Area Health Service HREC
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Ethics committee address [1]
269606
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Fremantle Hospital Alma St Fremantle Wa 6160
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Ethics committee country [1]
269606
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Australia
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Date submitted for ethics approval [1]
269606
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23/08/2011
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Approval date [1]
269606
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Ethics approval number [1]
269606
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Summary
Brief summary
There is a well established association between rheumatoid arthritis (RA) and bronchiectasis. It has been observed that patients who suffer RA are between 10 and 30 times more likely to develop bronchiectasis. The aetiology of this association is unknown. Mannose-binding lectin (MBL) is a component of the immune system which is active in fighting infection. It is thought that a deficiency in MBL may predispose individuals to infection especially if there is coexisting immunodeficiency. This study seeks to find an association between MBL deficiency and the development of bronchiectasis in patients with RA as a means to providing insight into the association between the two diseases.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33019
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Address
33019
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Country
33019
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Phone
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Fax
33019
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Email
33019
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Contact person for public queries
Name
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Dr Krista Makin
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Address
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Fremantle Hospital Alma St Fremantle WA 6160
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Country
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Australia
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Phone
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+61 8 9431 3333
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Fax
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Email
16266
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kristasims2000@yahoo.com.au
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Contact person for scientific queries
Name
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Dr Krista Makin
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Address
7194
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Fremantle Hospital Alma St Fremantle WA 6160
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Country
7194
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Australia
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Phone
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+61 8 9431 3333
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Fax
7194
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Email
7194
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kristasims2000@yahoo.com.au
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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.
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