xml: <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/NCT05963061</url>
    </required_header>
    <id_info>
      <org_study_id>CML Observatory</org_study_id>
      <nct_id>NCT05963061</nct_id>
    </id_info>
    <brief_title>Chronic Myeloid Leukemia (CML) Real-Life Database</brief_title>
    <official_title>Chronic Myeloid Leukemia (CML) Real-Life Database</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Clermont-Ferrand</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bicetre Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Central Hospital, Nancy, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CH Annecy Genevois</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rennes University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hopital Paul Brousse</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Versailles Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Hospitalier Emile Roux</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital, Limoges</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Clermont-Ferrand</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Establish the largest possible real-life cohort collecting long-term follow-up of a maximum&#xD;
        number of CML patients in order to carry out observational studies: epidemiological,&#xD;
        identification of subgroups according to their response to treatment, evaluation of new&#xD;
        molecules in real life, therapeutic discontinuations, impact of the evolution of&#xD;
        recommendations, etc.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Observational study collecting real-life clinico-biological data from patients with CML. Data&#xD;
        are collected prospectively and retrospectively, from diagnosis and throughout the long-term&#xD;
        follow-up of CML (follow up continues after treatment stopped).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 16, 2014</start_date>
    <completion_date type="Anticipated">April 16, 2034</completion_date>
    <primary_completion_date type="Anticipated">April 16, 2034</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>30 Years</target_duration>
    <primary_outcome>
      <measure>Clinical and biological data collection</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
      <description>Aims of the registry are the collection of clinical data to gain further insights about patients's CML treated with ITK's (treatment, prognosis, therapeutical response).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)</measure>
      <time_frame>At diagnosis</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI with evaluation of weight and height</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of major molecular response (MMR) with transcript BCR::ABL in %</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of molecular response MR4 with transcript BCR::ABL in %</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of molecular response MR4.5 with transcript BCR::ABL in %</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of molecular response MR5 with transcript BCR::ABL in %</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of cytogenetic response</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of TKI efficacy based on transcript BCR::ABL in %</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of TKI tolerance (adverses events)</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Listing of major medical history of patient's CML</measure>
      <time_frame>Until death or last follow up (up to 30 years)</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">3500</enrollment>
    <condition>Chronic Myeloid Leukemia (CML)</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Any patient with a diagnose of CML&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient diagnosed for chronic myelocytic leukemia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  CML allograft without TKI treatment&#xD;
  &#xD;
            -  Refusal or inability to sign the consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marc BERGER, MD</last_name>
      <role>Study Director</role>
      <affiliation>University Hospital, Clermont-Ferrand</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lise Laclautre</last_name>
      <phone>04 73 75 11 95</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CH Annecy Genevois</name>
        <address>
          <city>Annecy</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Anne Parry, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospital, Caen</name>
        <address>
          <city>Caen</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Atchroue Johnson Ansah, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU Clemront-Ferrand</name>
        <address>
          <city>Clermont-Ferrand</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Marc Berger, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Emile Roux</name>
        <address>
          <city>Le Puy-en-Velay</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Vanessa Pante, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospital, Limoges</name>
        <address>
          <city>Limoges</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Amelie Penot, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Hospital, Nancy</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Agnès Guerci-Bresler, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Bicetre Hospital</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Ali Turhan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hopital Paul Brousse</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Laurence Legros, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rennes University Hospital</name>
        <address>
          <city>Rennes</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Martine Escoffre-Barbe, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Universitaire de Saint Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Denis Guyotat, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospital, Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Françoise Huguet, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Versailles Hospital</name>
        <address>
          <city>Versailles</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Philippe Rousselot, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <link>
      <url>https://link.springer.com/article/10.1007/s00277-022-04955-z</url>
      <description>Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukaemia: Data from the French observatory</description>
    </link>
    <results_reference>
      <citation>Saugues S, Lambert C, Daguenet E, Ansah HJ, Turhan A, Huguet F, Guerci-Bresler A, Tchirkov A, Hamroun D, Hermet E, Pereira B, Berger MG. Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukemia: data from the French observatory. Ann Hematol. 2022 Oct;101(10):2241-2255. doi: 10.1007/s00277-022-04955-z. Epub 2022 Aug 30.</citation>
      <PMID>36040480</PMID>
    </results_reference>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Leukemia</keyword>
    <keyword>Leukemia, Myeloid</keyword>
    <keyword>Chronic myeloid leukemia</keyword>
    <keyword>Chronic, BCR::ABL Positive</keyword>
    <keyword>Hematologic Malignancies</keyword>
    <keyword>Tyrosine kinase inhibitor (TKI)</keyword>
    <keyword>Targeted therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Leukemia, Myeloid</mesh_term>
      <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963061
  org study id: CML Observatory
  nct id: NCT05963061
  lead sponsor: 
  collaborator: 
  collaborator: 
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  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Establish the largest possible real-life cohort collecting long-term follow-up of a maximum
        number of CML patients in order to carry out observational studies: epidemiological,
        identification of subgroups according to their response to treatment, evaluation of new
        molecules in real life, therapeutic discontinuations, impact of the evolution of
        recommendations, etc.
  Observational study collecting real-life clinico-biological data from patients with CML. Data
        are collected prospectively and retrospectively, from diagnosis and throughout the long-term
        follow-up of CML (follow up continues after treatment stopped).
  observational model: Cohort
  time perspective: Other
  measure: Clinical and biological data collection
  time frame: Until death or last follow up (up to 30 years)
  description: Aims of the registry are the collection of clinical data to gain further insights about patients's CML treated with ITK's (treatment, prognosis, therapeutical response).
  measure: Prognosis score for CML (Sokal, ELTS, Eutos, Hasford)
  time frame: At diagnosis
  measure: BMI with evaluation of weight and height
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of major molecular response (MMR) with transcript BCR::ABL in %
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of molecular response MR4 with transcript BCR::ABL in %
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of molecular response MR4.5 with transcript BCR::ABL in %
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of molecular response MR5 with transcript BCR::ABL in %
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of cytogenetic response
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of TKI efficacy based on transcript BCR::ABL in %
  time frame: Until death or last follow up (up to 30 years)
  measure: Evaluation of TKI tolerance (adverses events)
  time frame: Until death or last follow up (up to 30 years)
  measure: Calcul in month of the duration of maintenance TFR (treatment free remission) after stop TKI for thérapeutic response
  time frame: Until death or last follow up (up to 30 years)
  measure: Listing of major medical history of patient's CML
  time frame: Until death or last follow up (up to 30 years)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Marc BERGER, MD
  role: Study Director
  affiliation: University Hospital, Clermont-Ferrand
  last name: Lise Laclautre
  phone: 04 73 75 11 95
  email: promo_interne_drci@chu-clermontferrand.fr
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
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  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  country: France
  url: https://link.springer.com/article/10.1007/s00277-022-04955-z
  description: Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukaemia: Data from the French observatory
  citation: Saugues S, Lambert C, Daguenet E, Ansah HJ, Turhan A, Huguet F, Guerci-Bresler A, Tchirkov A, Hamroun D, Hermet E, Pereira B, Berger MG. Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukemia: data from the French observatory. Ann Hematol. 2022 Oct;101(10):2241-2255. doi: 10.1007/s00277-022-04955-z. Epub 2022 Aug 30.
  PMID: 36040480
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  sharing ipd: No