<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/NCT03275480</url>
  </required_header>
  <id_info>
    <org_study_id>BDD-SMD-IPC</org_study_id>
    <nct_id>NCT03275480</nct_id>
  </id_info>
  <brief_title>Institut Paoli Calmettes Myelodysplastic Syndromes Database</brief_title>
  <official_title>Institut Paoli Calmettes Myelodysplastic Syndromes Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</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>
      Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2016</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">January 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Survival of patients with myelodysplastic syndrome(MDS)</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival of all patients with MDS who are taken in charge in Institut Paoli Calmettes Cancer Center</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collection of patients characteristics</measure>
    <time_frame>10 years</time_frame>
    <description>Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with new diagnosis of Myelodysplastic Syndromes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a diagnosis of Myelodysplastic Syndromes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Norbert Vey, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Genre, MD</last_name>
    <phone>+33491223778</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lilian Laborde</last_name>
    <phone>+33491223778</phone>
    <email>abordel@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique GENRE, MD</last_name>
      <phone>0491223778</phone>
      <phone_ext>33</phone_ext>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact>
    <contact_backup>
      <last_name>Lilian LABORDE</last_name>
      <phone>0491223778</phone>
      <phone_ext>33</phone_ext>
      <email>labordel@ipc.unicancer.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT03275480
org study id: BDD-SMD-IPC
nct id: NCT03275480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Database of Institut Paoli-Calmettes patients diagnosed with Myelodysplastic Syndromes
observational model: Cohort
time perspective: Other
measure: Survival of patients with myelodysplastic syndrome(MDS)
time frame: 10 years
description: Overall survival of all patients with MDS who are taken in charge in Institut Paoli Calmettes Cancer Center
measure: Collection of patients characteristics
time frame: 10 years
description: Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Norbert Vey, Pr
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: Dominique Genre, MD
phone: +33491223778
email: drci.up@ipc.unicancer.fr
last name: Lilian Laborde
phone: +33491223778
email: abordel@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome