Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
425 participants
INTERVENTIONAL
2020-02-05
2020-03-06
Brief Summary
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Detailed Description
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1. 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.
2. 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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
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.
SCREENING
DOUBLE
Study Groups
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Sample tested in less than one-hour
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.
Spartan Cube CYP2C19 System
Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
Samples tested greater than 24 hours
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.
Spartan Cube CYP2C19 System
Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
Interventions
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Spartan Cube CYP2C19 System
Using buccal material, determine the genotype of the \*2, \*3 and \*17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Mount Sinai Services
UNKNOWN
Spartan Bioscience Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shaimaa Ahmed, PhD
Role: PRINCIPAL_INVESTIGATOR
Spartan Bioscience Inc.
Locations
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Mount Sinai Services
Toronto, Ontario, Canada
Countries
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Other Identifiers
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VNV-00229
Identifier Type: -
Identifier Source: org_study_id
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