<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/NCT02986620</url>
  </required_header>
  <id_info>
    <org_study_id>AML1516</org_study_id>
    <nct_id>NCT02986620</nct_id>
  </id_info>
  <brief_title>Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gruppo Italiano Malattie EMatologiche dell'Adulto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gruppo Italiano Malattie EMatologiche dell'Adulto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study where there are no interventions planned. Investigators will only collect&#xD;
      data already in the patient's history and analyze it. Particularly, we are interested in&#xD;
      molecular data from AML patients.&#xD;
&#xD;
      This means that patients will follow their regular diagnostic and clinical practice. The&#xD;
      analyses will be conducted according to the routine diagnostic and clinical practice as well&#xD;
      and no additional blood withdrawal will be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted as follows:&#xD;
&#xD;
        1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2&#xD;
           mutations will be retrospectively collected in the centers that have already introduced&#xD;
           IDH1/2 mutational screening in their practice from cases collected according to standard&#xD;
           procedure (Ficoll and lysis in RLT buffer).&#xD;
&#xD;
        2. Prospective phase: each participating center already performing IDH1/2 mutational status&#xD;
           on samples of their AML patients at diagnosis or relapse - on freshly isolate&#xD;
           mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient&#xD;
           preparation - will prospectively collect the clinical and molecular data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Number of patients with the IDH mutations in AML at initial diagnosis.</measure>
    <time_frame>At two years from study entry.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with the IDH mutations in AML at relapse.</measure>
    <time_frame>At three years from study entry.</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">388</enrollment>
  <condition>AML, Adult</condition>
  <arm_group>
    <arm_group_label>AML patients</arm_group_label>
    <description>Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>IDH mutation test performed at diagnosis or relapse until January 31st, 2019.</intervention_name>
    <description>Observation of the test result.</description>
    <arm_group_label>AML patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult AML patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Signed written informed consent according to ICH/EU/GCP and national local laws (if&#xD;
             applicable);&#xD;
&#xD;
          -  AML patients;&#xD;
&#xD;
          -  Age ≥18;&#xD;
&#xD;
          -  IDH mutation test performed at diagnosis or relapse until January 31st, 2019.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  AML M3 subtype according to the FAB classification;&#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>Giovanni Martinelli</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Teresa Voso</last_name>
    <role>Study Director</role>
    <affiliation>U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia</name>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto di Ematologia &quot;Lorenzo e A. Seragnoli&quot; - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica</name>
      <address>
        <city>Meldola</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico G. Martino</name>
      <address>
        <city>Messina</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UO Ematologia _AOU Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Padova - Ematologia ed Immunologia Clinica</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AU Policlinico &quot;Paiolo Giaccone&quot;</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asl Di Piacenza, Ospedale &quot;Guglielmo Da Saliceto&quot; - Ematologia E Centro Trapianti</name>
      <address>
        <city>Piacenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IFO Istituto Nazionale Tumori Regina Elena</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università Cattolica del Sacro Cuore - Policlinico A.Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi - Policlinico di Tor Vergata</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi - Policlinico Tor Vergata</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asui Di Udine - Presidio Ospedaliero &quot;Santa Maria Della Misericordia&quot; - Clinica Ematologica</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 31, 2021</last_update_submitted>
  <last_update_submitted_qc>December 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</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>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02986620
org study id: AML1516
nct id: NCT02986620
lead sponsor: 
has dmc: No
This is a study where there are no interventions planned. Investigators will only collect
      data already in the patient's history and analyze it. Particularly, we are interested in
      molecular data from AML patients.

      This means that patients will follow their regular diagnostic and clinical practice. The
      analyses will be conducted according to the routine diagnostic and clinical practice as well
      and no additional blood withdrawal will be performed.
The study will be conducted as follows:

        1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2
           mutations will be retrospectively collected in the centers that have already introduced
           IDH1/2 mutational screening in their practice from cases collected according to standard
           procedure (Ficoll and lysis in RLT buffer).

        2. Prospective phase: each participating center already performing IDH1/2 mutational status
           on samples of their AML patients at diagnosis or relapse - on freshly isolate
           mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient
           preparation - will prospectively collect the clinical and molecular data.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with the IDH mutations in AML at initial diagnosis.
time frame: At two years from study entry.
measure: Number of patients with the IDH mutations in AML at relapse.
time frame: At three years from study entry.
arm group label: AML patients
description: Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
intervention type: Genetic
intervention name: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
description: Observation of the test result.
arm group label: AML patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni Martinelli
role: Study Chair
affiliation: Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
last name: Maria Teresa Voso
role: Study Director
affiliation: U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
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country: Italy
responsible party type: Sponsor
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No