Trial Outcomes & Findings for Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing (NCT NCT01718535)
NCT ID: NCT01718535
Last Updated: 2013-08-28
Results Overview
The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.
Recruitment status
COMPLETED
Target enrollment
327 participants
Primary outcome timeframe
After second pass result is complete (~3hours)
Results posted on
2013-08-28
Participant Flow
Recruitment of study participants was performed without knowledge of participant genotypes by enrolling associates of operators and associates of Spartan Bioscience and Mount Sinai Services.
Participant milestones
| Measure |
*1/*1 CYP2C19 Genotype
|
*1/*2 CYP2C19 Genotype
|
*2/*2 CYP2C19 Genotype
|
*1/*3 CYP2C19 Genotype
|
*3/*3 CYP2C19 Genotype
|
*1/*17 CYP2C19 Genotype
|
*17/*17 CYP2C19 Genotype
|
*2/*3 CYP2C19 Genotype
|
*2/*17 CYP2C19 Genotype
|
*3/*17 CYP2C19 Genotype
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
95
|
19
|
8
|
1
|
40
|
11
|
6
|
15
|
1
|
|
Overall Study
First Pass
|
128
|
94
|
19
|
7
|
1
|
39
|
11
|
6
|
15
|
1
|
|
Overall Study
COMPLETED
|
130
|
95
|
19
|
7
|
1
|
40
|
11
|
6
|
15
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
*1/*1 CYP2C19 Genotype
|
*1/*2 CYP2C19 Genotype
|
*2/*2 CYP2C19 Genotype
|
*1/*3 CYP2C19 Genotype
|
*3/*3 CYP2C19 Genotype
|
*1/*17 CYP2C19 Genotype
|
*17/*17 CYP2C19 Genotype
|
*2/*3 CYP2C19 Genotype
|
*2/*17 CYP2C19 Genotype
|
*3/*17 CYP2C19 Genotype
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Bidirectional Sequencing not possible
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing
Baseline characteristics by cohort
| Measure |
*1/*1 CYP2C19 Genotype
n=130 Participants
|
*1/*2 CYP2C19 Genotype
n=95 Participants
|
*2/*2 CYP2C19 Genotype
n=19 Participants
|
*1/*3 CYP2C19 Genotype
n=7 Participants
|
*3/*3 CYP2C19 Genotype
n=1 Participants
|
*1/*17 CYP2C19 Genotype
n=40 Participants
|
*17/*17 CYP2C19 Genotype
n=11 Participants
|
*2/*3 CYP2C19 Genotype
n=6 Participants
|
*2/*17 CYP2C19 Genotype
n=15 Participants
|
*3/*17 CYP2C19 Genotype
n=1 Participants
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Gender Not Collected
|
130 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
325 Participants
n=42 Participants
|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
124 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
315 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
130 participants
n=5 Participants
|
95 participants
n=7 Participants
|
19 participants
n=5 Participants
|
7 participants
n=4 Participants
|
1 participants
n=21 Participants
|
40 participants
n=10 Participants
|
11 participants
n=115 Participants
|
6 participants
n=24 Participants
|
15 participants
n=42 Participants
|
1 participants
n=42 Participants
|
325 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: After second pass result is complete (~3hours)The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.
Outcome measures
| Measure |
*1/*1 CYP2C19 Genotype
n=130 Participants
|
*1/*2 CYP2C19 Genotype
n=95 Participants
|
*2/*2 CYP2C19 Genotype
n=19 Participants
|
*1/*3 CYP2C19 Genotype
n=7 Participants
|
*3/*3 CYP2C19 Genotype
n=1 Participants
|
*1/*17 CYP2C19 Genotype
n=40 Participants
|
*17/*17 CYP2C19 Genotype
n=11 Participants
|
*2/*3 CYP2C19 Genotype
n=6 Participants
|
*2/*17 CYP2C19 Genotype
n=15 Participants
|
*3/*17 CYP2C19 Genotype
n=1 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Agreement
|
100 Percent Agreement
Interval 98.0 to 100.0
|
100 Percent Agreement
Interval 97.0 to 100.0
|
100 Percent Agreement
Interval 88.0 to 100.0
|
100 Percent Agreement
Interval 72.0 to 100.0
|
100 Percent Agreement
Interval 27.0 to 100.0
|
100 Percent Agreement
Interval 94.0 to 100.0
|
100 Percent Agreement
Interval 80.0 to 100.0
|
100 Percent Agreement
Interval 69.0 to 100.0
|
100 Percent Agreement
Interval 85.0 to 100.0
|
100 Percent Agreement
Interval 27.0 to 100.0
|
Adverse Events
*1/*1 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*1/*2 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*2/*2 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*1/*3 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*3/*3 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*1/*17 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*17/*17 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*2/*3 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*2/*17 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
*3/*17 CYP2C19 Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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