Spartan FRX Project Reproducibility Study

NCT01676298 | Completed Results

• 1 other identifier: 01001686
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 3

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. The objective of the study is to evaluate the performance of the FRX System under multivariate conditions including different days, sites, operators and systems.

Conditions

Analytical Reproducibility of a Medical Device

Keywords

Cyp2C19; Genotyping; Spartan; Reproducibility

Outcome Measures

Primary Outcomes (1)

• Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.

  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).

  After second pass result is complete (~3h)

Interventions

Spartan FRX CYP2C19 Test System DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

8 Individuals with predetermined CYP2C19 \*2,\*3 and \*17 genotypes

You may qualify if:

• Above 16 years of age
• Must have required genotype

You may not qualify if:

• None

Sponsors & Collaborators

• Spartan Bioscience Inc.: lead
• Children's Hospital of Eastern Ontario: collaborator
• Ottawa Hospital Research Institute: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (3)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L6, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Mount Sinai Services

Toronto, Ontario, M5G 1Z5, Canada

Location

Results Point of Contact

• Title: Dr. Chris Harder
• Organization: Spartan Bioscience Inc.

chris.harder@spartanbio.com

613-228-7756

Study Officials

• Chris JE Harder, PhD

  Spartan Bioscience

  PRINCIPAL INVESTIGATOR

• Azar Azad, PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Marc Desjardins, PhD

  Ottawa Hosptial Research Institute

  PRINCIPAL INVESTIGATOR

• Jean McGowan-Jordan, PhD

  Children's Hospital of Eastern Ontario

  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: August 28, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 7, 2013
• Results First Posted: January 7, 2013

Record last verified: 2012-12

Locations

CA (3)