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Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test

Sponsor
Sequenom, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01835483
Collaborator
(none)
867
Enrollment
3
Locations
2
Duration (Months)
289
Patients Per Site
144.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    De-identified banked genomic DNA samples derived from whole blood from subjects with suspected thrombophilia will be collected from one or more clinical sites. Three clinical laboratory sites will analyze the samples with the FII/FVL Test. Bi-directional DNA sequencing will be performed on all samples at an independent core reference laboratory.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    867 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia
    Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Performance of the MassPLEX Factor II/V Leiden Test [Samples are collected at time of suspected thrombotic event.]

      Overall percent agreement of the FII/FVL Test results to the bi-directional DNA sequencing results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • suspected thrombophilia

    • 18 years of age or older

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sequenom Center for Molecular Medicine Grand Rapids Michigan United States 49503
    2 Oregon Health & Science University Portland Oregon United States 97239
    3 The Methodist Hospital Research Institute Houston Texas United States 77030

    Sponsors and Collaborators

    • Sequenom, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sequenom, Inc.
    ClinicalTrials.gov Identifier:
    NCT01835483
    Other Study ID Numbers:
    • SQNM-FVL-300
    First Posted:
    Apr 19, 2013
    Last Update Posted:
    Jan 20, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Thrombosis

    Study Results

    No Results Posted as of Jan 20, 2014