Clincosm LogoSign in Get a demo

MAHM: MS Detection of Somatic Mutations in Hematological Malignancies

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03771079
Collaborator
(none)
200
Enrollment
1
Location
12
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies
    Actual Study Start Date :
    Dec 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2019
    Anticipated Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS) [10 months]

      Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

    Eligibility Criteria

    Criteria

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

    • adults >18 years old

    • anonymized samples already studied with NGS in Strasbourg university hematology center for somatic mutations

    • non-opposition of the patient for testing the archive sample with the new method

    Exclusion Criteria:

    • opposition for testing the archive sample with the new method

    • insufficient archival material

    • patient under protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laboratoire d'Hématologie Strasbourg France 67098

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Laurent MAUVIEUX, MD, PhD, University Hospital, Strasbourg, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT03771079
    Other Study ID Numbers:
    • 7259
    First Posted:
    Dec 10, 2018
    Last Update Posted:
    Dec 26, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Hematological Malignancy
    mutations
    NGS sequencing
    mass spectrometry
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Dec 26, 2018