<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/NCT03828942</url>
  </required_header>
  <id_info>
    <org_study_id>CIC1421-19-01</org_study_id>
    <nct_id>NCT03828942</nct_id>
  </id_info>
  <brief_title>Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)</brief_title>
  <acronym>HeMATOX</acronym>
  <official_title>Monitoring the HeMAtological TOXicity of Drugs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Hospitalier Pitie-Salpetriere</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several drugs and chemotherapies seem to have an impact on the hematological system. This&#xD;
      study investigates reports of hematological toxicities, including the International&#xD;
      classification of disease ICD-10 for treatments in the World Health Organization (WHO) global&#xD;
      Individual Case Safety Report (ICSR) database (VigiBase).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several drugs and chemotherapies seem to have an impact on the hematological system and are&#xD;
      responsible of a wide range of hematological side effects. Those are poorly described, due to&#xD;
      the modification of the pharmacopeia, and the recent recognition of several of these adverse&#xD;
      events. This study investigates the main characteristics of patients affected by rare&#xD;
      hematological side effects imputed to drugs. A causality assessment according to the WHO-UMC&#xD;
      (World Health Organization - Uppsala Monitoring Center) is systematically applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 8, 2023</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Causality assessment of reported hematological toxicities events according to the WHO system</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the type of hematological toxicity depending on the category of drug</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the duration of treatment when the toxicity happens (role of cumulative dose)</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the drug-drug interactions associated with adverse events</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the pathologies (cancer) for which the incriminated drugs have been prescribed</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the population of patients having hematological toxicity adverse event</measure>
    <time_frame>to 01/02/2019</time_frame>
    <description>Case reported in the World Health Organization (WHO) database of individual safety case reports</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Hematological Abnormality</condition>
  <condition>Hematotoxicity</condition>
  <arm_group>
    <arm_group_label>Hematological toxicity induced by drugs and chemotherapies</arm_group_label>
    <description>Case reported in the World Health Organization (WHO) of hematological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>drug inducing hematological toxicity</intervention_name>
    <description>Drugs susceptible to induce hematological toxicities</description>
    <arm_group_label>Hematological toxicity induced by drugs and chemotherapies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with a drug that could be reported in the WHO's pharmacovigilance database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case reported in the WHO's pharmacovigilance database till 01/02/2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronology not compatible between the drug and the toxicity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhumatology department, CHU Strasbourg, Hautepierre hospital</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Groupe Hospitalier Pitie-Salpetriere</investigator_affiliation>
    <investigator_full_name>Joe Elie Salem</investigator_full_name>
    <investigator_title>Assistant director, clinical investigation center Paris Est</investigator_title>
  </responsible_party>
  <keyword>advrese event</keyword>
  <keyword>hematotoxicity</keyword>
  <keyword>drugs</keyword>
  <keyword>chemotherapies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03828942
org study id: CIC1421-19-01
nct id: NCT03828942
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Several drugs and chemotherapies seem to have an impact on the hematological system. This
      study investigates reports of hematological toxicities, including the International
      classification of disease ICD-10 for treatments in the World Health Organization (WHO) global
      Individual Case Safety Report (ICSR) database (VigiBase).
Several drugs and chemotherapies seem to have an impact on the hematological system and are
      responsible of a wide range of hematological side effects. Those are poorly described, due to
      the modification of the pharmacopeia, and the recent recognition of several of these adverse
      events. This study investigates the main characteristics of patients affected by rare
      hematological side effects imputed to drugs. A causality assessment according to the WHO-UMC
      (World Health Organization - Uppsala Monitoring Center) is systematically applied.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Causality assessment of reported hematological toxicities events according to the WHO system
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the type of hematological toxicity depending on the category of drug
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the drug-drug interactions associated with adverse events
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
measure: Description of the population of patients having hematological toxicity adverse event
time frame: to 01/02/2019
description: Case reported in the World Health Organization (WHO) database of individual safety case reports
arm group label: Hematological toxicity induced by drugs and chemotherapies
description: Case reported in the World Health Organization (WHO) of hematological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity
intervention type: Drug
intervention name: drug inducing hematological toxicity
description: Drugs susceptible to induce hematological toxicities
arm group label: Hematological toxicity induced by drugs and chemotherapies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Groupe Hospitalier Pitie-Salpetriere
investigator full name: Joe Elie Salem
investigator title: Assistant director, clinical investigation center Paris Est
mesh term: Congenital Abnormalities
sharing ipd: Undecided