ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01676298
Previous Study | Return to List | Next Study

Spartan FRX Project Reproducibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Spartan Bioscience

Reporting Groups
  Description
*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.

Participant Flow:   Overall Study
    *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
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
*1/*1 CYP2C19 Genotype No text entered.
*1/*2 CYP2C19 Genotype No text entered.
*2/*2 CYP2C19 Genotype No text entered.
*3/*1 CYP2C19 Genotype No text entered.
*1/*17 CYP2C19 Genotype No text entered.
*17/*17 CYP2C19 Genotype No text entered.
*2/*3 CYP2C19 Genotype No text entered.
*2/*17 CYP2C19 Genotype No text entered.
Total Total of all reporting groups

Baseline Measures
   *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 
Overall Participants Analyzed 
[Units: Participants]
 1   1   1   1   1   1   1   1   8 
Age 
[Units: Participants]
                 
<=18 years   0   0   0   0   1   0   0   0   1 
Between 18 and 65 years   1   1   1   1   0   1   1   1   7 
>=65 years   0   0   0   0   0   0   0   0   0 
Gender 
[Units: Participants]
                 
Female   0   0   1   0   1   1   0   0   3 
Male   1   1   0   1   0   0   1   1   5 
Region of Enrollment 
[Units: Participants]
                 
Canada   1   1   1   1   1   1   1   1   8 


  Outcome Measures

1.  Primary:   Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.   [ Time Frame: After second pass result is complete (~3h) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: chris.harder@spartanbio.com



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