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Spartan Cube CYP2C19 Method Comparison Study

NCT04473586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2020-07-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mount Sinai Services

    collaborator UNKNOWN

  • Spartan Bioscience Inc.

    lead INDUSTRY

Principal Investigators

  • Shaimaa Ahmed, PhD · Spartan Bioscience Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473586 on ClinicalTrials.gov