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Spartan FRX Project Reproducibility Study

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ClinicalTrials.gov Identifier: NCT01676298
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
Ottawa Hospital Research Institute
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Spartan Bioscience Inc.

Study Type Observational
Study Design Time Perspective: Prospective
Condition Analytical Reproducibility of a Medical Device
Intervention Device: Spartan FRX CYP2C19 Test System
Enrollment 8
Recruitment Details A total of 8 individuals were recruited for a company pool of known suspected genotypes; each with a different CYP2C19 genotype confirmed prior to the study by bi-directional sequencing.
Pre-assignment Details Spartan Bioscience
Arm/Group Title *1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Hide Arm/Group Description Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing. Subject had genotype confirmed via bi-directional sequencing.
Period Title: Overall Study
Started 1 1 1 1 1 1 1 1
All Genotypes Confirmed With Reference 1 1 1 1 1 1 1 1
Participated in All Tests 1 1 1 1 1 1 1 1
Completed 1 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0
Arm/Group Title *1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 1 1 1 1 1 1 1 1 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Between 18 and 65 years
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
1
 100.0%
7
  87.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
Female
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
0
   0.0%
0
   0.0%
3
  37.5%
Male
1
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
 100.0%
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
1 1 1 1 1 1 1 1 8
1.Primary Outcome
Title Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
Hide Description

Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.

All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is "Inconclusive" for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement).

Time Frame After second pass result is complete (~3h)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title *1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Hide Arm/Group Description:
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Subject had genotype confirmed via bi-directional sequencing.
Overall Number of Participants Analyzed 1 1 1 1 1 1 1 1
Overall Number of Units Analyzed
Type of Units Analyzed: CYP2C19 Genotype
120 120 200 120 120 120 120 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Correct Calls
98.3
(95.1 to 99.4)
100
(97.8 to 100)
97.5
(95 to 98.8)
99.2
(96.4 to 99.8)
100
(97.8 to 100)
99.2
(96.4 to 99.8)
99.2
(96.4 to 99.8)
99.2
(96.4 to 99.8)
Time Frame Adverse events were monitored for the full duration of the trial (~2 months).
Adverse Event Reporting Description No adverse events were encountered.
 
Arm/Group Title *1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
*1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
*1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
*1/*1 CYP2C19 Genotype *1/*2 CYP2C19 Genotype *2/*2 CYP2C19 Genotype *3/*1 CYP2C19 Genotype *1/*17 CYP2C19 Genotype *17/*17 CYP2C19 Genotype *2/*3 CYP2C19 Genotype *2/*17 CYP2C19 Genotype
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Chris Harder
Organization: Spartan Bioscience Inc.
Phone: 613-228-7756 ext 778
Responsible Party: Spartan Bioscience Inc.
ClinicalTrials.gov Identifier: NCT01676298     History of Changes
Other Study ID Numbers: 01001686
First Submitted: August 28, 2012
First Posted: August 30, 2012
Results First Submitted: November 6, 2012
Results First Posted: January 7, 2013
Last Update Posted: January 7, 2013