Analytical Reproducibility of a Medical DeviceNCT01676298
Spartan FRX Project Reproducibility Study
An observational study of Analytical Reproducibility of a Medical Device, run by Spartan Bioscience Inc. at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analytical Reproducibility of a Medical Device
- What is being tested?
- Spartan FRX CYP2C19 Test System
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2012to Nov 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 8 Individuals with predetermined CYP2C19 *2,*3 and *17 genotypes
Who may be able to join
- Above 16 years of age
- Must have required genotype
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L6
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Mount Sinai Services
Toronto, Ontario, M5G 1Z5
About this study
Official title: Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.
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.
Read the detailed description
The FRX system is comprised of hardware and consumable components. The hardware components of the system include an Analyzer (thermal cycler with fluorescence detection capability), a notebook computer and a printer. The consumable component of the FRX system is a sample collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain reaction) amplification stages of the test.
The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide polymorphism) (*2, *3, *17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.
To perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and *17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the *2, *3 and *17 loci.
The objective of the study is to evaluate the performance of the FRX System under multivariate conditions. Specifically, the following variables will be included in the study:
- Test site - x3
- Operator - x6 (2 per site)
- Day - x15 (5 non-consecutive days per site)
- FRX System - x16
Test performance is defined as the number of correct genotype calls, expressed as a percentage of the total number of tests performed on the system.
For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be calculated using the score method for the % correct calls (i.e. % agreement).
Genotype results from the FRX system will be compared with results of DNA sequencing. The result of the FRX System test will be determined to be correct if the genotype calls for all three SNPs are identical to the genotypes determined by DNA sequencing for that sample/individual.
Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95% confidence limit of the total correct call rate per genotype is greater than or equal to 95%, based on second-pass results.
- Being tested
- Spartan FRX CYP2C19 Test System
- Keywords
- Cyp2C19, Genotyping, Spartan, Reproducibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spartan FRX CYP2C19 Test SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After second pass result is complete (~3h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Analytical Reproducibility of a Medical DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spartan Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Eastern Ontario, Ottawa Hospital Research Institute, Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Chris JE Harder, PhD, Principal investigator, Spartan BioscienceAzar Azad, PhD, Principal investigator, MOUNT SINAI HOSPITALMarc Desjardins, PhD, Principal investigator, Ottawa Hosptial Research InstituteJean McGowan-Jordan, PhD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676298
- Sponsor's protocol ID
- 01001686
- Status last verified
- Dec 2012
- First submitted
- 28 Aug 2012
- Last updated
- 7 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.
- ClinicalTrials.gov ID
- NCT01676298
- Acronym / sponsor ID
- 01001686
- Keywords
- Cyp2C19, Genotyping, Spartan, Reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spartan Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Eastern Ontario, Ottawa Hospital Research Institute, Mount Sinai Hospital, Canada
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 7 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The FRX system is comprised of hardware and consumable components. The hardware components of the system include an Analyzer (thermal cycler with fluorescence detection capability), a notebook computer and a printer. The consumable component of the FRX system is a sample collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain reaction) amplification stages of the test.
The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide polymorphism) (*2, *3, *17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.
To perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci *2, *3 and *17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the *2, *3 and *17 loci.
The objective of the study is to evaluate the performance of the FRX System under multivariate conditions. Specifically, the following variables will be included in the study:
- Test site - x3
- Operator - x6 (2 per site)
- Day - x15 (5 non-consecutive days per site)
- FRX System - x16
Test performance is defined as the number of correct genotype calls, expressed as a percentage of the total number of tests performed on the system.
For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be calculated using the score method for the % correct calls (i.e. % agreement).
Genotype results from the FRX system will be compared with results of DNA sequencing. The result of the FRX System test will be determined to be correct if the genotype calls for all three SNPs are identical to the genotypes determined by DNA sequencing for that sample/individual.
Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95% confidence limit of the total correct call rate per genotype is greater than or equal to 95%, based on second-pass results.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 8 Individuals with predetermined CYP2C19 *2,*3 and *17 genotypes
Key inclusion criteria (2 listed)
- Above 16 years of age
- Must have required genotype
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spartan FRX CYP2C19 Test System | Device | – |
Primary outcome
Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris JE Harder, PhD principal investigator
Spartan Bioscience
Azar Azad, PhD principal investigator
MOUNT SINAI HOSPITAL
Marc Desjardins, PhD principal investigator
Ottawa Hosptial Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analytical Reproducibility of a Medical Device, run by Spartan Bioscience Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System. (time frame: After second pass result is complete (~3h)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.