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Completed

NCT Number: NCT04473586

Spartan Cube CYP2C19 Method Comparison Study

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.

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Key information

Conditions

Genotyping Techniques

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Services

Toronto, Ontario, M5G1Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.

Exclusion criteria

  • Participants who have eaten drank or smoked in the past 30 minutes prior to collection.

Treatment and study plan

Spartan Cube CYP2C19 System

Device

Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.

Primary outcomes

  1. % 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

Sponsors and collaborators

Lead sponsor

Spartan Bioscience Inc.

Industry

Collaborators

  • Mount Sinai Services

Registry information

Official study title

Validation Protocol Spartan Cube CYP2C19- Method Comparison

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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