Genotyping TechniquesNCT04473573
Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study
A study testing Spartan Cube CYP2C19 System in people with Genotyping Techniques, run by Spartan Bioscience Inc. at 3 sites in Canada.
Trial summary
The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under multi-variant conditions including test site (three different test sites), operators (two operators per site), testing days (five non-consecutive days per site), and test kit lot (three different lots). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Genotyping Techniques
- What is being tested?
- Spartan Cube CYP2C19 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesCanada
- Study dates
- 31 Oct 2019to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- available for travel to three different sites, on 5 non-consecutive days.
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
The Univeristy of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
About this study
Official title: Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study
The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under multi-variant conditions including test site (three different test sites), operators (two operators per site), testing days (five non-consecutive days per site), and test kit lot (three different lots).
Read the detailed description
The reproducibility study (VNV-00227) is aimed at assessing the performance of the Spartan Cube CYP2C19 product under multi-variant conditions that include test site, operators, testing days, and reagent lots. The sections below address how these variables were tested.
This study will be performed by a total of six operators at three test sites. At each site, two operators will conduct buccal sample collection and analysis. Operators include individuals who are technologists, technicians, and/or nurses. The buccal samples will be loaded in the Cube within one hour after buccal swab collection. Furthermore, results will be generated using multiple platforms (Spartan Cube, computer, and printer) and the same platforms will be used at each site. At each site, a total of 64 (8 subjects/operator x 2 operators x 2 sessions x 2 sub-sessions (replicates)) tests will be run on five non-consecutive days. Each day includes 2 sessions and 2 sub-sessions (total 4 collection times) in which samples will be collected. Test subject to platform pairing is not required, results will be generated on one of the platforms per session. This means that each site will generate a total of 320(64 obs./day x 5 days) results over the entire duration of the study.
To determine lot-to-lot reproducibility of test kits, three different lots will be evaluated. For this, two lots will be tested at each site. Each operator will use two lots per session on each testing day. Each replicate only includes a single lot of test kits.
All results generated by the Spartan Cube CYP2C19 System will be compared with the bi-directional sequencing results.
- Conditions
- Genotyping Techniques
- Being tested
- Spartan Cube CYP2C19 System
- Keywords
- Reproducibility of Results, CYP2C19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spartan Cube CYP2C19 SystemDevice
Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
| Study group | Role | What they receive |
|---|---|---|
| Lot to Lot Reproducibility | Other | The purpose of this arm is to provide evidence to support that each lot of manufactured reagents for the Spartan Cube CYP2C19 Test produce the same result. Each participant, over the course of the study at the various sites, will be tested using 3 different lots of manufactured Spartan CYP2C19 Test Kits. Receives: Device: Spartan Cube CYP2C19 System |
| Site to Site Reproducibility | Other | The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when tested at different locations, produce the same result. Receives: Device: Spartan Cube CYP2C19 System |
| Operator Reproducibility | Other | The purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when collected and tested by different operators, produce the same result. Receives: Device: Spartan Cube CYP2C19 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
Determine % agreement across all tests conducted and bi-directional sequencing results
Measured: Through study completion; anticipated to be less than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start31 Oct 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genotyping TechniquesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All subjects receive the same number and type of test for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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, The Ottawa Hospital, The University of Ottawa Heart Institute
- Responsible party
- Sponsor
- Investigators
- Shaimaa Ahmed, PhD, Principal investigator, Spartan Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473573
- Sponsor's protocol ID
- VNV-00227
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study
- ClinicalTrials.gov ID
- NCT04473573
- Acronym / sponsor ID
- VNV-00227
- Conditions
- Genotyping Techniques
- Keywords
- Reproducibility of Results, CYP2C19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spartan Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Eastern Ontario, The Ottawa Hospital, The University of Ottawa Heart Institute
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study verifies that the Spartan Cube CYP2C19 System generates reproducible results under multi-variant conditions including test site (three different test sites), operators (two operators per site), testing days (five non-consecutive days per site), and test kit lot (three different lots).
Detailed description
The reproducibility study (VNV-00227) is aimed at assessing the performance of the Spartan Cube CYP2C19 product under multi-variant conditions that include test site, operators, testing days, and reagent lots. The sections below address how these variables were tested.
This study will be performed by a total of six operators at three test sites. At each site, two operators will conduct buccal sample collection and analysis. Operators include individuals who are technologists, technicians, and/or nurses. The buccal samples will be loaded in the Cube within one hour after buccal swab collection. Furthermore, results will be generated using multiple platforms (Spartan Cube, computer, and printer) and the same platforms will be used at each site. At each site, a total of 64 (8 subjects/operator x 2 operators x 2 sessions x 2 sub-sessions (replicates)) tests will be run on five non-consecutive days. Each day includes 2 sessions and 2 sub-sessions (total 4 collection times) in which samples will be collected. Test subject to platform pairing is not required, results will be generated on one of the platforms per session. This means that each site will generate a total of 320(64 obs./day x 5 days) results over the entire duration of the study.
To determine lot-to-lot reproducibility of test kits, three different lots will be evaluated. For this, two lots will be tested at each site. Each operator will use two lots per session on each testing day. Each replicate only includes a single lot of test kits.
All results generated by the Spartan Cube CYP2C19 System will be compared with the bi-directional sequencing results.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All subjects receive the same number and type of test for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Lot to Lot Reproducibility | Other | Device: Spartan Cube CYP2C19 SystemThe purpose of this arm is to provide evidence to support that each lot of manufactured reagents for the Spartan Cube CYP2C19 Test produce the same result. Each participant, over the course of the study at the various sites, will be tested using 3 different lots of manufactured Spartan CYP2C19 Test Kits. |
| Site to Site Reproducibility | Other | Device: Spartan Cube CYP2C19 SystemThe purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when tested at different locations, produce the same result. |
| Operator Reproducibility | Other | Device: Spartan Cube CYP2C19 SystemThe purpose of this arm was to provide supporting evidence that showed the same samples (subjects), when collected and tested by different operators, produce the same result. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- available for travel to three different sites, on 5 non-consecutive days.
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 Cube CYP2C19 SystemUsing buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System. | Device | Lot to Lot Reproducibility, Operator Reproducibility, Site to Site Reproducibility |
Primary outcome
% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
Time frame: Through study completion; anticipated to be less than 6 months
Determine % agreement across all tests conducted and bi-directional sequencing results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Shaimaa Ahmed, PhD principal investigator
Spartan Bioscience
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spartan Cube CYP2C19 System in people with Genotyping Techniques, 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 1 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 16 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing (time frame: Through study completion; anticipated to be less than 6 months). 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 16 Jul 2020.