Trial Outcomes & Findings for Spartan FRX Project Reproducibility Study (NCT NCT01676298)
NCT ID: NCT01676298
Last Updated: 2013-01-07
Results Overview
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).
COMPLETED
8 participants
After second pass result is complete (~3h)
2013-01-07
Participant Flow
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.
Spartan Bioscience
Participant milestones
| Measure |
*1/*1 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*1/*2 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*2 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*3/*1 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*1/*17 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*17/*17 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*3 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*17 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
All Genotypes Confirmed With Reference
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Participated in All Tests
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spartan FRX Project Reproducibility Study
Baseline characteristics by cohort
| Measure |
*1/*1 CYP2C19 Genotype
n=1 Participants
|
*1/*2 CYP2C19 Genotype
n=1 Participants
|
*2/*2 CYP2C19 Genotype
n=1 Participants
|
*3/*1 CYP2C19 Genotype
n=1 Participants
|
*1/*17 CYP2C19 Genotype
n=1 Participants
|
*17/*17 CYP2C19 Genotype
n=1 Participants
|
*2/*3 CYP2C19 Genotype
n=1 Participants
|
*2/*17 CYP2C19 Genotype
n=1 Participants
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
8 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: After second pass result is complete (~3h)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).
Outcome measures
| Measure |
*1/*1 CYP2C19 Genotype
n=120 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*1/*2 CYP2C19 Genotype
n=120 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*2 CYP2C19 Genotype
n=200 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*3/*1 CYP2C19 Genotype
n=120 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*1/*17 CYP2C19 Genotype
n=120 CYP2C19 Genotype
Subject had genotype confirmed via bi-directional sequencing.
|
*17/*17 CYP2C19 Genotype
n=1 Participants
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*3 CYP2C19 Genotype
n=1 Participants
Subject had genotype confirmed via bi-directional sequencing.
|
*2/*17 CYP2C19 Genotype
n=1 Participants
Subject had genotype confirmed via bi-directional sequencing.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
|
98.3 Percentage of Correct Calls
Interval 95.1 to 99.4
|
100 Percentage of Correct Calls
Interval 97.8 to 100.0
|
97.5 Percentage of Correct Calls
Interval 95.0 to 98.8
|
99.2 Percentage of Correct Calls
Interval 96.4 to 99.8
|
100 Percentage of Correct Calls
Interval 97.8 to 100.0
|
99.2 Percentage of Correct Calls
Interval 96.4 to 99.8
|
99.2 Percentage of Correct Calls
Interval 96.4 to 99.8
|
99.2 Percentage of Correct Calls
Interval 96.4 to 99.8
|
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60