Spartan Cube CYP2C19 Method Comparison Study

Genotyping Techniques Clinical Trial

Official title:

Validation Protocol Spartan Cube CYP2C19- Method Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473586
• Other study ID #: VNV-00229
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: March 6, 2020

Study information

• Verified date: July 2020
• Source: Spartan Bioscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

Sample holding time - two parts

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Genotyping Techniques

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Services	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Spartan Bioscience Inc.	Mount Sinai Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	Through study completion; anticipated to be less than 4 months