NCT01718535

Brief Summary

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \*2, \*3 and \*17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 28, 2013

Completed
Last Updated

August 28, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

October 29, 2012

Results QC Date

February 7, 2013

Last Update Submit

May 28, 2013

Conditions

Genotyping Techniques

Keywords

Cyp2C19GenotypingSpartanComparisonSequencing

Outcome Measures

Primary Outcomes (1)

  • Percent Agreement

    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.

    After second pass result is complete (~3hours)

Study Arms (1)

CYP2C19 Genotyping

Device: Spartan FRX CYP2C19 Test System

Interventions

Spartan FRX CYP2C19 Test SystemDEVICE
CYP2C19 Genotyping

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

320 Individuals with undetermined CYP2C19 \*2 \*3 and \*17 Genotypes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Services

Toronto, Ontario, M5G1Z5, Canada

Location

Results Point of Contact

Title
Azar Azad
Organization
Mount Sinai Services Inc.
aazad@mtsinai.on.ca
416-856-8545

Study Officials

  • Azar Azad, PhD

    Mount Sinai Hospital, Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

August 28, 2013

Results First Posted

August 28, 2013

Record last verified: 2013-05

Locations

CA(1)