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SAFE-Blood: A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04304612
Collaborator
(none)
500
Enrollment
1
Location
47.9
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of Analytical performances [day 1]

      Analytical performances

    Secondary Outcome Measures

    1. Number of Field evaluation [day 1]

      Field evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Samples having been tested positive or negative for the serological markers explored in the study
    Exclusion criteria:
    • to refuse to participate to the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Edouard TUAILLON, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04304612
    Other Study ID Numbers:
    • RECHMPL20_0141
    First Posted:
    Mar 11, 2020
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Serological assays
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections

    Study Results

    No Results Posted as of Sep 14, 2021