<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/NCT03755856</url>
  </required_header>
  <id_info>
    <org_study_id>GIMEMA-EORTC 1621-QLG-LG</org_study_id>
    <nct_id>NCT03755856</nct_id>
  </id_info>
  <brief_title>Long-term Outcomes for Acute Myeloid Leukemia Patients</brief_title>
  <acronym>1621-QLG-LG</acronym>
  <official_title>A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gruppo Italiano Malattie EMatologiche dell'Adulto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gruppo Italiano Malattie EMatologiche dell'Adulto</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>
      This international observational study aims at examining the patterns of health-related&#xD;
      quality of life differences between long-term acute myeloid leukemia patients and their&#xD;
      healthy peers from the general population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of differences in SF-36 scores</measure>
    <time_frame>At enrollment</time_frame>
    <description>The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.</measure>
    <time_frame>At enrollment</time_frame>
    <description>Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.</measure>
    <time_frame>At enrollment</time_frame>
    <description>Comparisons will be adjusted by age and sex, using the European reference values for the EORTC QLQ-C30. A subgroup analysis on elderly patients (i.e. 60+ patients) will be also performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.</measure>
    <time_frame>At enrollment</time_frame>
    <description>Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.</measure>
    <time_frame>At enrollment</time_frame>
    <description>Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">343</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Health-related quality of life</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study patients are acute myeloid leukemia long-term survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20%&#xD;
             blasts in the bone marrow), except acute promyelocytic leukemia (APL).&#xD;
&#xD;
          -  Age at AML diagnosis ≥ 18 years,&#xD;
&#xD;
          -  Date of AML diagnosis at least 5 years before study enrollment,&#xD;
&#xD;
          -  AML-free status at study enrollment,&#xD;
&#xD;
          -  Written informed consent provided.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major cognitive deficit or psychiatric problems hampering a self-reported evaluation,&#xD;
&#xD;
          -  Not speaking and reading the language of the participating country,&#xD;
&#xD;
          -  More than 75 years at the time of study enrollment,&#xD;
&#xD;
          -  Receiving any active treatment for AML at the time of study enrollment.&#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>Fabio Efficace</last_name>
    <role>Study Chair</role>
    <affiliation>GIMEMA Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frédéric Baron</last_name>
    <role>Study Director</role>
    <affiliation>European Organisation for Research and Treatment of Cancer - EORTC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesca Tartaglia</last_name>
    <phone>+39 06 441639837</phone>
    <email>f.tartaglia@gimema.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Johan Maertens</last_name>
    </contact>
    <investigator>
      <last_name>Johan Maertens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHR Citadelle-CHU</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aurélie Jaspers</last_name>
    </contact>
    <investigator>
      <last_name>Aurélie Jaspers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Liège</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Frédéric Baron</last_name>
    </contact>
    <investigator>
      <last_name>Frédéric Baron</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>KBC Rijeka</name>
      <address>
        <city>Rijeka</city>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Duska Petranovic</last_name>
    </contact>
    <investigator>
      <last_name>Dusca Petranovic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Zagreb</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Radovan Petranovic</last_name>
    </contact>
    <investigator>
      <last_name>Radovan Petranovic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Les Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xavier Thomas</last_name>
    </contact>
    <investigator>
      <last_name>Xavier Thomas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Attilio Olivieri</last_name>
    </contact>
    <investigator>
      <last_name>Attilio Olivieri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Albano</last_name>
    </contact>
    <investigator>
      <last_name>Francesco Albano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Ematologia Ospedale &quot; Monsignor Raffaele Dimiccoli&quot;</name>
      <address>
        <city>Barletta</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Giuseppe Tarantini</last_name>
    </contact>
    <investigator>
      <last_name>Giuseppe Tarantini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Divisione di Ematologia Ospedale A. Perrino</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Domenico Pastore</last_name>
    </contact>
    <investigator>
      <last_name>Domenico Pastore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ASL N.8 - Ospedale &quot;A. Businco&quot; - Struttura Complessa di Ematologia e CTMO</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Claudio Romani</last_name>
    </contact>
    <investigator>
      <last_name>Claudio Romani</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Di Raimondo</last_name>
    </contact>
    <investigator>
      <last_name>Francesco Di Raimondo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi</name>
      <address>
        <city>Cona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Ciccone</last_name>
    </contact>
    <investigator>
      <last_name>Maria Ciccone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria</name>
      <address>
        <city>Foggia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvana Franca Capalbo</last_name>
    </contact>
    <investigator>
      <last_name>Franca Capalbo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS_AOU San Martino-IST.Clinica Ematologica</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Massimo Lemoli</last_name>
    </contact>
    <investigator>
      <last_name>Roberto Massimo Lemoli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Fracchiolla</last_name>
    </contact>
    <investigator>
      <last_name>Nicola Fracchiolla</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria - Università degli Studi di Napoli &quot;Federico II&quot; - Facoltà di Medicina e Chirurgia</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabrizio Pane</last_name>
    </contact>
    <investigator>
      <last_name>Fabrizio Pane</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Angiolina Rocino</last_name>
    </contact>
    <investigator>
      <last_name>Angiolina Roccino</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro</name>
      <address>
        <city>Novara</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Monia Lunghi</last_name>
    </contact>
    <investigator>
      <last_name>Monia Lunghi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2</name>
      <address>
        <city>Orbassano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Daniela Cilloni</last_name>
    </contact>
    <investigator>
      <last_name>Daniela Cilloni</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Padova - Ematologia ed Immunologia Clinica</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Carmela Gurrieri</last_name>
    </contact>
    <investigator>
      <last_name>Carmela Gurrieri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.O. di Ematologia con trapianto - A.U. Policlinico &quot;Paolo Giaccone&quot;</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Enza Mitra</last_name>
    </contact>
    <investigator>
      <last_name>Maria Enza Mitra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.O. Ematologia e CTMO- AOU di Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Cugnola</last_name>
    </contact>
    <investigator>
      <last_name>Monica Cugnola</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto</name>
      <address>
        <city>Piacenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniele Vallisa</last_name>
    </contact>
    <investigator>
      <last_name>Daniele Vallisa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ematologia - Ospedale San Carlo</name>
      <address>
        <city>Potenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nunzio Filardi</last_name>
    </contact>
    <investigator>
      <last_name>Nunzio Filardi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Imovilli Annalisa</last_name>
    </contact>
    <investigator>
      <last_name>Imovilli Annalisa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Az. Ospedaliera &quot;Sant' Andrea&quot;-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agostino Tafuri</last_name>
    </contact>
    <investigator>
      <last_name>Agostino Tafuri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Divisione di Ematologia - Ospedale S.Eugenio</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo De Fabritiis</last_name>
    </contact>
    <investigator>
      <last_name>Paolo De Fabritiis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Maurillo</last_name>
    </contact>
    <investigator>
      <last_name>Luca Maurillo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simona Sica</last_name>
    </contact>
    <investigator>
      <last_name>Simona Sica</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roma Divisione Ematologia - Università Campus Bio-Medico</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Avvisati</last_name>
    </contact>
    <investigator>
      <last_name>Giuseppe Avvisati</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Università degli Studi &quot;Sapienza&quot; - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maurizio Martelli</last_name>
    </contact>
    <investigator>
      <last_name>Maurizio Martelli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.O. di Ematologia - Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Cascavilla</last_name>
    </contact>
    <investigator>
      <last_name>Nicola Cascavilla</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ematologia - AOU Sassari</name>
      <address>
        <city>Sassari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudio Fozza</last_name>
    </contact>
    <investigator>
      <last_name>Claudio Fozza</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ernesta Audisio</last_name>
    </contact>
    <investigator>
      <last_name>Ernesta Audisio</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Clinic of Hematology-Skopje</name>
      <address>
        <city>Skopje</city>
        <country>North Macedonia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Irina Panovska</last_name>
    </contact>
    <investigator>
      <last_name>Irina Panovska</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University hospital Bratislava</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martin Mistrik</last_name>
    </contact>
    <investigator>
      <last_name>Martin Mistrik</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UKC Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Matevz Skerget</last_name>
    </contact>
    <investigator>
      <last_name>Matevz Skerget</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maltem Yuksel</last_name>
    </contact>
    <investigator>
      <last_name>Maltem Yuksel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Italy</country>
    <country>North Macedonia</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</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</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</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/NCT03755856
org study id: GIMEMA-EORTC 1621-QLG-LG
nct id: NCT03755856
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This international observational study aims at examining the patterns of health-related
      quality of life differences between long-term acute myeloid leukemia patients and their
      healthy peers from the general population.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of differences in SF-36 scores
time frame: At enrollment
description: The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.
measure: Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
time frame: At enrollment
description: Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores
measure: QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.
time frame: At enrollment
description: Comparisons will be adjusted by age and sex, using the European reference values for the EORTC QLQ-C30. A subgroup analysis on elderly patients (i.e. 60+ patients) will be also performed.
measure: Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
time frame: At enrollment
description: Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
measure: Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
time frame: At enrollment
description: Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
intervention type: Other
intervention name: Questionnaire
description: Health-related quality of life
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabio Efficace
role: Study Chair
affiliation: GIMEMA Foundation
last name: Frédéric Baron
role: Study Director
affiliation: European Organisation for Research and Treatment of Cancer - EORTC
last name: Francesca Tartaglia
phone: +39 06 441639837
email: f.tartaglia@gimema.it
facility: 
status: Not yet recruiting
contact: 
investigator: 
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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investigator: 
facility: 
status: Recruiting
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facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
contact: 
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country: Belgium
country: Croatia
country: France
country: Italy
country: North Macedonia
country: Slovakia
country: Slovenia
country: Turkey
country: Macedonia, The Former Yugoslav Republic of
country: Netherlands
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: Undecided