Genotyping TechniquesNCT04473586
Spartan Cube CYP2C19 Method Comparison Study
A study testing Spartan Cube CYP2C19 System in people with Genotyping Techniques, run by Spartan Bioscience Inc. at 1 site in Canada.
Trial summary
The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing. 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
- 425 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2020to 6 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
- Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.
Who cannot join
- Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Protocol Spartan Cube CYP2C19- Method Comparison
The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.
Read the detailed description
Sample holding time - two parts
- Sample tested in less than one-hour a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.
- Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.
- Conditions
- Genotyping Techniques
- Being tested
- Spartan Cube CYP2C19 System
- Keywords
- Method Comparison, 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 |
|---|---|---|
| Sample tested in less than one-hour | Other | Buccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (<1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject. Receives: Device: Spartan Cube CYP2C19 System |
| Samples tested greater than 24 hours | Other | Buccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject. 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 4 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 start5 Feb 2020
- Primary completion6 Mar 2020
- Study completion6 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 will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2. Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spartan Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Services
- Responsible party
- Sponsor
- Investigators
- Shaimaa Ahmed, PhD, Principal investigator, Spartan Bioscience Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473586
- Sponsor's protocol ID
- VNV-00229
- 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
- Validation Protocol Spartan Cube CYP2C19- Method Comparison
- ClinicalTrials.gov ID
- NCT04473586
- Acronym / sponsor ID
- VNV-00229
- Conditions
- Genotyping Techniques
- Keywords
- Method Comparison, CYP2C19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Spartan Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mount Sinai Services
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 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 aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.
Detailed description
Sample holding time - two parts
- Sample tested in less than one-hour a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.
- Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All subjects will experienced the same number of buccal and saliva samples collected. This means all subjects will participate in Arm 1 and have materials collected at the same time in the event they are enrolled in arm 2. Based on enrollment numbers and their immediate genotype, it will be determined at that time if the subject will participate in the second arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Sample tested in less than one-hour | Other | Device: Spartan Cube CYP2C19 SystemBuccal samples will be collected and analyzed on the Spartan Cube CYP2C19 System immediately (<1hr). The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject. |
| Samples tested greater than 24 hours | Other | Device: Spartan Cube CYP2C19 SystemBuccal samples will be collected, stored and then analyzed on the Spartan Cube CYP2C19 System greater than 24 hours after collection. The Spartan Cube CYP2C19 results will be compared with bi-directional sequencing results generated by a third part from a saliva sample collected from the same subject. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.
Key exclusion criteria (1 listed)
- Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
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 | Sample tested in less than one-hour, Samples tested greater than 24 hours |
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 4 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 Inc.
1 site 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 1 site 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 1 site 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 4 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.