Spartan Cube CYP2C19 Method Comparison Study

NCT04473586 | Completed

• 1 other identifier: VNV-00229
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genotyping Techniques

Keywords

Method Comparison; CYP2C19

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (2)

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.

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.

Device: Spartan Cube CYP2C19 System

Interventions

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.

Sample tested in less than one-hour; Samples tested greater than 24 hours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Spartan Bioscience Inc.: lead
• Mount Sinai Services: collaborator

Study Sites (1)

Mount Sinai Services

Toronto, Ontario, M5G1Z5, Canada

Location

Study Officials

• Shaimaa Ahmed, PhD

  Spartan Bioscience Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Bi-directional sequencing results and Spartan results will not be shared with participants. The investigator will not see the bi-directional sequencing results.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: February 5, 2020
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)