Study Results
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View full resultsBasic Information
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COMPLETED
8 participants
OBSERVATIONAL
2012-08-31
2012-11-30
Brief Summary
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Detailed Description
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The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide polymorphism) (\*2, \*3, \*17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.
To perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci \*2, \*3 and \*17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the \*2, \*3 and \*17 loci.
The objective of the study is to evaluate the performance of the FRX System under multivariate conditions. Specifically, the following variables will be included in the study:
* Test site - x3
* Operator - x6 (2 per site)
* Day - x15 (5 non-consecutive days per site)
* FRX System - x16
Test performance is defined as the number of correct genotype calls, expressed as a percentage of the total number of tests performed on the system.
For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be calculated using the score method for the % correct calls (i.e. % agreement).
Genotype results from the FRX system will be compared with results of DNA sequencing. The result of the FRX System test will be determined to be correct if the genotype calls for all three SNPs are identical to the genotypes determined by DNA sequencing for that sample/individual.
Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95% confidence limit of the total correct call rate per genotype is greater than or equal to 95%, based on second-pass results.
Conditions
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Study Design
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PROSPECTIVE
Interventions
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Spartan FRX CYP2C19 Test System
Eligibility Criteria
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Inclusion Criteria
* Must have required genotype
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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Children's Hospital of Eastern Ontario
OTHER
Ottawa Hospital Research Institute
OTHER
Mount Sinai Hospital, Canada
OTHER
Spartan Bioscience Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris JE Harder, PhD
Role: PRINCIPAL_INVESTIGATOR
Spartan Bioscience
Azar Azad, PhD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Marc Desjardins, PhD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hosptial Research Institute
Jean McGowan-Jordan, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Eastern Ontario
Locations
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Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Mount Sinai Services
Toronto, Ontario, Canada
Countries
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Other Identifiers
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01001686
Identifier Type: -
Identifier Source: org_study_id
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