Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
691 participants
OBSERVATIONAL
2021-07-12
2022-02-11
Brief Summary
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Detailed Description
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Subjects will be recruited for this study through the CALIPER initiative and will include healthy children and adolescents in the community and in outpatient clinics at the Hospital for Sick Children (HSC). Since all participants will be recruited through the CALIPER initiative, the CALIPER consent forms will be used to obtain consent from each child and their parent/guardian. These forms obtain consent to use the samples to develop reference intervals for a range of tests. This study aims to measure hematology parameters in these samples and is therefore encompassed within the CALIPER consent. Recruitment will focus on subjects from three ethnic groups: Caucasians, Hispanics, and South Asians. A total of 960 subjects will be recruited for this study through the CALIPER initiative. The total sample size was determined by considering the requirement of 60-120 samples per partition for five age groups (0-\<1 years, 1-\<5 years, 5-\<10 years, 10-\<15 years, 15-\<19 years). Each age group will consist of an equal number of females and males. Additional samples may be required if data analysis suggests further age and/or sex partitioning for specific parameters.
Each subject will provide a blood sample, which will be collected through the CALIPER initiative. These samples will be analyzed as part of this study in a secondary-use/retrospective fashion. Specifically, fresh whole blood specimens will be collected in K2EDTA tubes, placed in biohazard bags, stored on ice, and analyzed on the Mindray hematology platform within 8 hours of collection. All available hematology parameters for the BC-6800Plus will be measured (37 report and 48 research hematology parameters, as per the user manual). All procedures will be performed according to the user manual. Mindray quality control materials will be used to monitor the performance of the assays during the study. HSC will retain all quality controls data, maintenance record and reagents/calibrators lot numbers. Quality controls will be run daily and analysis of the CALIPER samples will proceed only after all the quality control (QC) data are acceptable.
Data analysis will be performed by the CALIPER team in accordance with Clinical \& Laboratory Standards Institute (CLSI) EP28-A3c guidelines on defining, establishing, and verifying reference intervals in the clinical laboratory. The statistical approach for reference interval establishment has been described in-depth previously. In brief, analyte concentrations will be plotted against age and colour-coded by sex. Following visual inspection, extreme outliers will be removed and suspected age- and sex-specific partitions will be confirmed using the Harris and Boyd statistical method. Normality of data will be qualitatively assessed using quantile-quantile plots and quantitatively assessed using the Shapiro-Wilk's test. If skewed, the Box-Cox transformation will be applied in an effort to transform the data to a normal distribution. Outliers will be subsequently identified and removed using the Tukey or adjusted Tukey method for Gaussian and non-Gaussian data distributions, respectively. Reference intervals for partitions with ≥120 participants will be calculated using the nonparametric method. Reference intervals for partitions with ≥40 and \<120 participants (60 for group 0-\<1 years and 1-\<5 years, 120 for group 5-\<10 years, 10-\<15 years and 15-\<19 years) will be calculated using the robust method. 90% percent confidence intervals will also be calculated for the lower and upper limit of each reference interval. Ethnic-specific reference intervals will be calculated if sample size for each ethnic group is adequate. Otherwise, reference value distributions for South Asian and Hispanic children will be compared to those of Caucasian children.
Oversight Authority (additional information)
* This study is regulated by 'Canada: Health Canada'
* This study has been reviewed and approved by 'Canada: Ethics Review Committee'
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Healthy CALIPER Participants
Healthy community children and adolescents recruited through the CALIPER initiative as well as healthy children and adolescents recruited from outpatient clinics at the Hospital for Sick Children through the CALIPER initiative. Blood samples from these participants will be tested on the Mindray BC-6800Plus device to measure hematology parameters and establish reference intervals.
Hematology Parameters
Measurement of hematology parameters on BC-6800Plus
Interventions
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Hematology Parameters
Measurement of hematology parameters on BC-6800Plus
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of prescription medications within 2 weeks of collection
* Acute illness within 7 days of collection
* Pregnancy
18 Years
ALL
Yes
Sponsors
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MINDRAY
UNKNOWN
The Hospital for Sick Children
OTHER
Responsible Party
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Khosrow Adeli
Head of Clinical Biochemistry
Principal Investigators
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Khosrow Khosrow, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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REB1000069402
Identifier Type: -
Identifier Source: org_study_id
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