<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771079</url>
  </required_header>
  <id_info>
    <org_study_id>7259</org_study_id>
    <nct_id>NCT03771079</nct_id>
  </id_info>
  <brief_title>MS Detection of Somatic Mutations in Hematological Malignancies</brief_title>
  <acronym>MAHM</acronym>
  <official_title>Evaluation of MassArray Platform Versus Illumina Miseq for the Detection of Driver Mutations in Hematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS&#xD;
      sequencing. This powerful approach is nevertheless time consuming and its costs represent&#xD;
      limitation for its availability. An original approach is now available, using mass&#xD;
      spectrometry (MS). In this study the analytical performance of both methods will be compared,&#xD;
      using samples that were previously analyzed by NGS.&#xD;
&#xD;
      The goal of the study is to assess whether MS can represent or not a faster and cheaper way&#xD;
      to detect key point mutations in patients suffering from hematological malignancies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)</measure>
    <time_frame>10 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hematological Malignancy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        anonymized samples from patients already studied with NGS in Strasbourg university&#xD;
        hematology center for somatic mutations&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults &gt;18 years old&#xD;
&#xD;
          -  anonymized samples already studied with NGS in Strasbourg university hematology center&#xD;
             for somatic mutations&#xD;
&#xD;
          -  non-opposition of the patient for testing the archive sample with the new method&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opposition for testing the archive sample with the new method&#xD;
&#xD;
          -  insufficient archival material&#xD;
&#xD;
          -  patient under protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent MAUVIEUX, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent MAUVIEUX, MD, PhD</last_name>
    <phone>33 3 88 12 75 27</phone>
    <email>laurent.mauvieux@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Laboratoire d'Hématologie</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent MAUVIEUX, MD, PhD</last_name>
      <phone>33 3 88 12 75 27</phone>
      <email>laurent.mauvieux@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Laurent MIGUET, MD</last_name>
      <phone>33 3 88 12 75 27</phone>
      <email>Laurentyannick.miguet@chru-strasbourg.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Laurent MAUVIEUX, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent MIGUET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hematological Malignancy</keyword>
  <keyword>mutations</keyword>
  <keyword>NGS sequencing</keyword>
  <keyword>mass spectrometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771079
org study id: 7259
nct id: NCT03771079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
observational model: Cohort
time perspective: Retrospective
measure: Detection of somatic mutations in hematological malignancies by using mass spectrometry (MS)
time frame: 10 months
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent MAUVIEUX, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Strasbourg, France
last name: Laurent MAUVIEUX, MD, PhD
phone: 33 3 88 12 75 27
email: laurent.mauvieux@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms