Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000047695
Ethics application status
Approved
Date submitted
24/12/2013
Date registered
17/01/2014
Date last updated
1/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study investigating age and sex specific reference ranges for periostin in a general adult population without asthma or any other significant respiratory co-morbidity
Scientific title
A study investigating age and sex specific reference ranges for periostin in a general adult population without asthma or any other significant respiratory co-morbidity
Secondary ID [1] 283890 0
Nil known
Universal Trial Number (UTN)
U1111-1149-9827
Trial acronym
PER01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periostin levels 290625 0
Condition category
Condition code
Public Health 291017 291017 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum Periostin levels
Serum Periostin levels will be measured at a single visit (at enrolment), via a specific periostin laboratory assay.
Intervention code [1] 288373 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291003 0
Reference ranges (90% confidence intervals for the general population) will be determined for each age band within the population sample by a general linear model (ANOVA). Serum periostin level results will be provided by the specific periostin laboratory assay and statistically assessed, as above.
Timepoint [1] 291003 0
Single visit - Serum Periostin level measured at enrolment visit, using a specific periostin laboratory assay.
Secondary outcome [1] 305804 0
Associations between periostin and non-asthmatic health conditions, as captured by a study specific general health questionnaire (e.g. diabetes)
Timepoint [1] 305804 0
Single visit - assessed at enrolment visit
Secondary outcome [2] 305805 0
Associations between periostin and Spirometry (Forced Expiratory Volume in 1 second [FEV1] and Forced Vital Capacity [FVC]) parameters, as measured by a spirometer
Timepoint [2] 305805 0
Single visit - assessed at enrolment visit
Secondary outcome [3] 305806 0
Associations between periostin and Fractional Exhaled Nitric Oxide (FeNO) level, as measured by a NIOX MINO device
Timepoint [3] 305806 0
Single visit - assessed at enrolment visit
Secondary outcome [4] 305807 0
Associations between periostin and full blood count including white cell differential, as measured by laboratory blood samples
Timepoint [4] 305807 0
Single visit - assessed at enrolment visit
Secondary outcome [5] 305808 0
Associations between periostin and serum creatinine, as measured by laboratory blood samples
Timepoint [5] 305808 0
Single visit - assessed at enrolment visit
Secondary outcome [6] 305809 0
Associations between periostin and serum IgE, as measured by laboratory blood samples
Timepoint [6] 305809 0
Single visit - assessed at enrolment visit
Secondary outcome [7] 305810 0
Association between periostin and ethnicity, as self-recorded by participants according to NZ Ministry of Health protocols, via study worksheets
Timepoint [7] 305810 0
Single visit - assessed at enrolment visit
Secondary outcome [8] 306137 0
Associations between periostin and urea, measured by laboratory blood samples
Timepoint [8] 306137 0
Single visit - assessed at enrolment visit
Secondary outcome [9] 306138 0
Associations between periostin and electrolytes, as measured by laboratory blood samples
Timepoint [9] 306138 0
Single visit - assessed at enrolment visit
Secondary outcome [10] 308072 0
Exploratory outcomes analysing relationships between periostin level and immune mediated biomarkers, as measured by laboratory assays
Timepoint [10] 308072 0
Single visit - assessed at enrolment visit
Secondary outcome [11] 308073 0
Exploratory outcomes analysing relationships between periostin level and RNA- based biomarkers, as measured by laboratory assay
Timepoint [11] 308073 0
Single visit - assessed at enrolment visit
Secondary outcome [12] 308074 0
Exploratory outcomes analysing relationships between periostin level and DNA- based biomarkers, as measured by laboratory assay
Timepoint [12] 308074 0
Single visit - assessed at enrolment visit

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide written informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Doctor’s diagnosis of Asthma, Bronchitis or COPD
Wheezing or use of respiratory inhalers in the past 12 months
Known pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months
Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc).
Bone fracture within the last 3 months
Systemic Corticosteroids within the last 3 months
Active (current, or within the 3 weeks prior to the visit) upper or lower respiratory tract infection
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
The sample size is based on the recommendations of the Australian Association of Clinical Biochemists as reported in: Defining, establishing and verifying reference intervals in the clinical laboratory: Approved guidelines 3rd edition. CLSI document C28-A3, Wayne PA. Clinical and Laboratory Standards Institute 2008.
Reference ranges (90% confidence intervals for the general population) will be determined for each age band within the population sample by a general linear model (ANOVA). Initial analysis will be carried out on a non-transformed scale however if a highly skew distribution is found analyses will be done on the log transformed scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2014
Actual
24/01/2014
Date of last participant enrolment
Anticipated
30/09/2014
Actual
15/07/2014
Date of last data collection
Anticipated
Actual
2/10/2014
Sample size
Target
500
Accrual to date
Final
480
Recruitment outside Australia
Country [1] 5659 0
New Zealand
State/province [1] 5659 0
Wellington

Funding & Sponsors
Funding source category [1] 288359 0
Commercial sector/Industry
Name [1] 288359 0
Genentech Inc
Country [1] 288359 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287066 0
None
Name [1] 287066 0
Address [1] 287066 0
Country [1] 287066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290240 0
Northern B HDEC
Ethics committee address [1] 290240 0
Ethics committee country [1] 290240 0
New Zealand
Date submitted for ethics approval [1] 290240 0
18/11/2013
Approval date [1] 290240 0
23/12/2013
Ethics approval number [1] 290240 0
13/NTB/183

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44654 0
Prof Richard Beasley
Address 44654 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6242, New Zealand
Country 44654 0
New Zealand
Phone 44654 0
+64 4 805 0147
Fax 44654 0
Email 44654 0
[email protected]
Contact person for public queries
Name 44655 0
Rachel Caswell-Smith
Address 44655 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6242, New Zealand
Country 44655 0
New Zealand
Phone 44655 0
+64 4 805 0247
Fax 44655 0
Email 44655 0
[email protected]
Contact person for scientific queries
Name 44656 0
Rachel Caswell-Smith
Address 44656 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6242, New Zealand
Country 44656 0
New Zealand
Phone 44656 0
+64 4 805 0247
Fax 44656 0
Email 44656 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
SourceTitleYear of PublicationDOI
Dimensions AIReference ranges for serum periostin in a population without asthma or chronic obstructive pulmonary disease2016https://doi.org/10.1111/cea.12763
N.B. These documents automatically identified may not have been verified by the study sponsor.