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Residual Sample Collection for Respiratory Viral Panel

Sponsor
GenMark Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT02049918
Collaborator
(none)
1,487
Enrollment
1
Location
24
Duration (Months)
62
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.

    Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1487 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)
    Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Sample collection study only [prospective and retrospective sample collection]

      This is an IVD Diagnostic study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Sample from patients exhibiting signs/symptoms of respiratory viral infection

    • All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.

    Exclusion Criteria:
    • Samples that are incorrectly de-identified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033

    Sponsors and Collaborators

    • GenMark Diagnostics

    Investigators

    • Principal Investigator: Wallace Green, PhD, Milton S. Hershey Medical Center
    • Principal Investigator: Michelle Fennell, MHA, MT(ASCP), Ingalls Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GenMark Diagnostics
    ClinicalTrials.gov Identifier:
    NCT02049918
    Other Study ID Numbers:
    • CTP0006
    First Posted:
    Jan 30, 2014
    Last Update Posted:
    Dec 28, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by GenMark Diagnostics
    Respiratory viruses
    Additional relevant MeSH terms:
    Adenoviridae Infections
    Virus Diseases

    Study Results

    No Results Posted as of Dec 28, 2015