Spartan Cube CYP2C19 Method Comparison Study

July 15, 2020 updated by: Spartan Bioscience Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1Z5
        • Mount Sinai Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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.
OTHER: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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
Through study completion; anticipated to be less than 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spartan Bioscience Inc.

Collaborators

Mount Sinai Services

Investigators

  • Principal Investigator: Shaimaa Ahmed, PhD, Spartan Bioscience Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2020

Primary Completion (ACTUAL)

March 6, 2020

Study Completion (ACTUAL)

March 6, 2020

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (ACTUAL)

July 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VNV-00229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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