<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/NCT04412811</url>
  </required_header>
  <id_info>
    <org_study_id>CYTOALLO GITMO-AMCLI SURVEY</org_study_id>
    <nct_id>NCT04412811</nct_id>
  </id_info>
  <brief_title>Prospective Survey of CMV, Herpesviruses Infections and Diseases in Allo-HSCT</brief_title>
  <acronym>CYTOALLOSURVEY</acronym>
  <official_title>A Prospective, Multicenter Survey of Cytomegalovirus (CMV) and Other Herpesviruses Infections and Diseases in Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) Recipients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gruppo Italiano Trapianto di Midollo Osseo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Policlinico Umberto I</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gruppo Italiano Trapianto di Midollo Osseo</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>
      Prospective observational study of epidemiological surveillance, multicenter, non-profit,&#xD;
      spontaneous, Italian with objective to describe the incidence of CMV infections and diseases&#xD;
      in adult and pediatric patients undergoing allo-HSCT during the first 6 months from&#xD;
      transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment)&#xD;
      from GITMO investigational centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study of epidemiological surveillance, multicenter,&#xD;
      non-profit, spontaneous, italian on patients submitted to allogeneic haematopoietic stem cell&#xD;
      transplantation organized under the auspices of the Gruppo Italiano Trapianti di Midollo&#xD;
      Osseo that involves the principal Centres active in transplantation of any kind of&#xD;
      hematopoietic stem cells in Italy.&#xD;
&#xD;
      Allogeneic haematopoietic stem cell transplantation patients continue to be one of the&#xD;
      highest risk categories for developing viral infections. Cytomegalovirus infection is the&#xD;
      leading viral cause of morbidity and mortality and HHV6 and EBV are other major causes of&#xD;
      complications in transplant. The risk of these infections is directly related to the type of&#xD;
      transplant.&#xD;
&#xD;
      A better and continuous monitoring of Cytomegalovirus and other herpesviruses complication in&#xD;
      this setting would contribute to a better knowledge of the evolving epidemiology and would&#xD;
      lead to a better use of diagnostic strategies and of preventive and therapeutic measures.&#xD;
&#xD;
      This study is aimed to identify epidemiological characteristics of allogeneic haematopoietic&#xD;
      stem cell transplantation patients developing cytomegalovirus and other herpesviruses&#xD;
      infections, risk factors, diagnostic peculiarities and factors that may guide to pre-emptive&#xD;
      therapy versus prophylaxis strategies.&#xD;
&#xD;
      Virological monitoring and health care resources utilization in Allogeneic haematopoietic&#xD;
      stem cell transplantation recipients according to the different risk of viral infection will&#xD;
      be also assessed. This prospective analysis will provide useful information for local&#xD;
      clinicians to define tailored antiviral strategies in line with the change of transplantation&#xD;
      procedures.&#xD;
&#xD;
      All consecutive patients submitted to allogeneic haematopoietic stem cell transplantation&#xD;
      will be prospectively monitored for Cytomegalovirus Cytomegalovirus, Herpesvirus human 6 and&#xD;
      Virus Epstein-Barr infections and diseases during the six months from transplant, because&#xD;
      most of viral infections and diseases occur within this period after transplant. Risk&#xD;
      factors, incidence and prognostic factors of each viral infection and disease, as well as&#xD;
      diagnostic and therapeutic strategies employed in the various transplant centers, will be&#xD;
      evaluated in the overall population and in subpopulations according to different transplant&#xD;
      characteristics.&#xD;
&#xD;
      The incidence of these infections and diseases will be also collected and described according&#xD;
      to the different types of transplant and underlying disease conditions.&#xD;
&#xD;
      The Secondary Objectives are:&#xD;
&#xD;
      To assess the factors that may affect the incidence and the prognosis of allogeneic&#xD;
      haematopoietic stem cell transplantation infections and diseases, as well as of Herpesvirus&#xD;
      human 6 and Virus Epstein-Barr infections and related diseases To assess the impact of&#xD;
      allogeneic haematopoietic stem cell transplantation infections and diseases on the overall&#xD;
      and attributable mortality at 12 months from the transplant To describe the virological&#xD;
      diagnostic strategies of allogeneic haematopoietic stem cell transplantation, Herpesvirus&#xD;
      human 6 and Virus Epstein-Barr infections and the allogeneic haematopoietic stem cell&#xD;
      transplantation specific immunological reconstitution tests used in the various centres To&#xD;
      describe the antiviral strategies employed in the various centers and in the various&#xD;
      subpopulations of transplant patients with focus on use of antiviral drugs in prophylaxis and&#xD;
      therapy and use of allogeneic haematopoietic stem cell transplantation -specific intravenous&#xD;
      IVIG in prophylaxis and therapy To evaluate the impact of a local strategy about use of&#xD;
      antiviral drugs and allogeneic haematopoietic stem cell transplantation -specific IVIG in&#xD;
      prophylaxis and therapy on the epidemiological findings, the clinical evolution of the&#xD;
      allogeneic haematopoietic stem cell transplantation infections and diseases and on the Health&#xD;
      Care Resources utilization (diagnostic procedures, pharmaco-utilization, hospitalization,&#xD;
      outpatient visits).&#xD;
&#xD;
      A web system data entry will be used for this study. Data will be stored using specific&#xD;
      e-CRFs designed by GITMO committee and includes mainly descriptive variables. Data Center&#xD;
      will perform extensive consistency checks and issue electronic Query Forms in case of&#xD;
      inconsistent data. Follow-up period for the evaluation of survival will be from the date of&#xD;
      transplant until 12 months post-transplant or death. However, patients may not have 12 months&#xD;
      follow up and if the patients are not having 12 months of observation due to lost to follow&#xD;
      up and not due to mortality, these patients characteristics will be compared with the rest of&#xD;
      the patients in order to ascertain there is no bias or estimate the bias.&#xD;
&#xD;
      The study will be conducted according to the principles of Good Clinical Practice, the&#xD;
      current Italian and European laws and regulations, in agreement with the declaration of&#xD;
      Helsinki. The protocol has been written and the study will be conducted according to The&#xD;
      International Council for Harmonisation of Technical Requirements for Pharmaceuticals for&#xD;
      Human Use Harmonized Tripartite Guideline for Good Clinical Practice, issued by the European&#xD;
      Union. The responsible Local Ethical Committee approval must be obtained before starting the&#xD;
      trial. A copy of the patient informed consent form must be submitted to the appropriate&#xD;
      authority or committee, together with the protocol for written approval. Written approval of&#xD;
      the protocol and informed consent by the responsible and appropriate authority or committee&#xD;
      must be obtained prior to recruitment of patients to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cytomegalovirus infection</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytomegalovirus disease</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Herpesvirus human 6 infection</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of human 6 infection after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Herpesvirus human 6 disease</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of human 6 disease after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virus Epstein-Barr infection</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of Virus Epstein-Barr infections after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virus Epstein-Barr disease</measure>
    <time_frame>6 months from transplant</time_frame>
    <description>incidence of Virus Epstein-Barr disease after allogeneic haematopoietic stem cell transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>These outcome measures will be assessed at 1 year from transplant</time_frame>
    <description>OS is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival (DFS)</measure>
    <time_frame>These outcome measures will be assessed at 1 year from transplant</time_frame>
    <description>DFS is defined as the probability of being alive free of disease at any point in time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant Related Mortality (TRM)</measure>
    <time_frame>These outcome measures will be assessed at 1 year from transplant</time_frame>
    <description>TRM was defined as death due to any transplantation-related cause other than disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse risk (RR)</measure>
    <time_frame>These outcome measures will be assessed at 1 year from transplant</time_frame>
    <description>RR or risk ratio is the ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Graft-versus-Host Disease</measure>
    <time_frame>These outcome measures will be assessed at 100 days from transplant</time_frame>
    <description>cumulative incidence of acute GvHD (grade II-IV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic graft-versus-host disease</measure>
    <time_frame>These outcome measures will be assessed at 1 year from transplant</time_frame>
    <description>cumulative incidence and severity of chronic graft-versus-host disease</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Hematologic Diseases</condition>
  <condition>Stem Cell Transplant Complications</condition>
  <condition>Cytomegalovirus Viremia</condition>
  <condition>Herpesvirus Infection</condition>
  <arm_group>
    <arm_group_label>Patients with hematological disease</arm_group_label>
    <description>Adult and children allogenic Hematopoietic stem cell transplantation recipients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and children allogenic Hematopoietic stem cell transplantation recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prospective observational study of epidemiological surveillance, multicenter,&#xD;
             non-profit, spontaneous, Italian with objective to describe the incidence of CMV&#xD;
             infections and diseases in adult and pediatric patients undergoing allo-HSCT during&#xD;
             the first 6 months from transplant. This study will evaluate approximately 1500&#xD;
             subjects, with competitive enrolment from GITMO investigational centers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of consent Written information&#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>Corrado Girmenia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Policlinico Umberto I</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UO Ematologia e TMO - Ospedale C. Panico</name>
      <address>
        <city>Tricase</city>
        <state>Lecce</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Ospedali Riuniti</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mazzoni</name>
      <address>
        <city>Ascoli Piceno</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.S. G. Moscati</name>
      <address>
        <city>Avellino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Bari-Ematologia con trapianti</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Ematologia - Ospedali Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico S.Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Orsola</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Regionale Generale- Divisione Ematologia</name>
      <address>
        <city>Bolzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Spedali Civili di Brescia- USD - TMO Adulti</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Locale Br1 Ospedale &quot;A. Perrino</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTMO PO &quot;Businco&quot; A.O. &quot;G. Brotzu&quot;</name>
      <address>
        <city>Cagliari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ferrarotto</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle</name>
      <address>
        <city>Cuneo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza</name>
      <address>
        <city>Foggia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU-IRCCS San Martino-IST</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Gaslini</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico VIto Fazzi</name>
      <address>
        <city>Lecce</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Integrata</name>
      <address>
        <city>Mestre</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Ematologia - Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Gerardo</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU S. Giovanni di Dio e Ruggi D'Aragona</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uoc Sit Tmo</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaliera Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Maria della Misericordia</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara</name>
      <address>
        <city>Pescara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Carlo</name>
      <address>
        <city>Potenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli</name>
      <address>
        <city>Reggio Calabria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arciospedale S. M. Novella</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Bambin Gesù</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano (MI)</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Moscati</name>
      <address>
        <city>Taranto</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU CIttà della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Regina Margherita</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Santa Maria della Misericordia</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico GB Rossi</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haematopoietic transplantation, CMV, Herpesviruses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Viremia</mesh_term>
    <mesh_term>Herpesviridae Infections</mesh_term>
    <mesh_term>Hematologic Diseases</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/NCT04412811
org study id: CYTOALLO GITMO-AMCLI SURVEY
nct id: NCT04412811
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective observational study of epidemiological surveillance, multicenter, non-profit,
      spontaneous, Italian with objective to describe the incidence of CMV infections and diseases
      in adult and pediatric patients undergoing allo-HSCT during the first 6 months from
      transplant. This study will evaluate approximately 1500 subjects (with competitive enrolment)
      from GITMO investigational centers.
This is a prospective observational study of epidemiological surveillance, multicenter,
      non-profit, spontaneous, italian on patients submitted to allogeneic haematopoietic stem cell
      transplantation organized under the auspices of the Gruppo Italiano Trapianti di Midollo
      Osseo that involves the principal Centres active in transplantation of any kind of
      hematopoietic stem cells in Italy.

      Allogeneic haematopoietic stem cell transplantation patients continue to be one of the
      highest risk categories for developing viral infections. Cytomegalovirus infection is the
      leading viral cause of morbidity and mortality and HHV6 and EBV are other major causes of
      complications in transplant. The risk of these infections is directly related to the type of
      transplant.

      A better and continuous monitoring of Cytomegalovirus and other herpesviruses complication in
      this setting would contribute to a better knowledge of the evolving epidemiology and would
      lead to a better use of diagnostic strategies and of preventive and therapeutic measures.

      This study is aimed to identify epidemiological characteristics of allogeneic haematopoietic
      stem cell transplantation patients developing cytomegalovirus and other herpesviruses
      infections, risk factors, diagnostic peculiarities and factors that may guide to pre-emptive
      therapy versus prophylaxis strategies.

      Virological monitoring and health care resources utilization in Allogeneic haematopoietic
      stem cell transplantation recipients according to the different risk of viral infection will
      be also assessed. This prospective analysis will provide useful information for local
      clinicians to define tailored antiviral strategies in line with the change of transplantation
      procedures.

      All consecutive patients submitted to allogeneic haematopoietic stem cell transplantation
      will be prospectively monitored for Cytomegalovirus Cytomegalovirus, Herpesvirus human 6 and
      Virus Epstein-Barr infections and diseases during the six months from transplant, because
      most of viral infections and diseases occur within this period after transplant. Risk
      factors, incidence and prognostic factors of each viral infection and disease, as well as
      diagnostic and therapeutic strategies employed in the various transplant centers, will be
      evaluated in the overall population and in subpopulations according to different transplant
      characteristics.

      The incidence of these infections and diseases will be also collected and described according
      to the different types of transplant and underlying disease conditions.

      The Secondary Objectives are:

      To assess the factors that may affect the incidence and the prognosis of allogeneic
      haematopoietic stem cell transplantation infections and diseases, as well as of Herpesvirus
      human 6 and Virus Epstein-Barr infections and related diseases To assess the impact of
      allogeneic haematopoietic stem cell transplantation infections and diseases on the overall
      and attributable mortality at 12 months from the transplant To describe the virological
      diagnostic strategies of allogeneic haematopoietic stem cell transplantation, Herpesvirus
      human 6 and Virus Epstein-Barr infections and the allogeneic haematopoietic stem cell
      transplantation specific immunological reconstitution tests used in the various centres To
      describe the antiviral strategies employed in the various centers and in the various
      subpopulations of transplant patients with focus on use of antiviral drugs in prophylaxis and
      therapy and use of allogeneic haematopoietic stem cell transplantation -specific intravenous
      IVIG in prophylaxis and therapy To evaluate the impact of a local strategy about use of
      antiviral drugs and allogeneic haematopoietic stem cell transplantation -specific IVIG in
      prophylaxis and therapy on the epidemiological findings, the clinical evolution of the
      allogeneic haematopoietic stem cell transplantation infections and diseases and on the Health
      Care Resources utilization (diagnostic procedures, pharmaco-utilization, hospitalization,
      outpatient visits).

      A web system data entry will be used for this study. Data will be stored using specific
      e-CRFs designed by GITMO committee and includes mainly descriptive variables. Data Center
      will perform extensive consistency checks and issue electronic Query Forms in case of
      inconsistent data. Follow-up period for the evaluation of survival will be from the date of
      transplant until 12 months post-transplant or death. However, patients may not have 12 months
      follow up and if the patients are not having 12 months of observation due to lost to follow
      up and not due to mortality, these patients characteristics will be compared with the rest of
      the patients in order to ascertain there is no bias or estimate the bias.

      The study will be conducted according to the principles of Good Clinical Practice, the
      current Italian and European laws and regulations, in agreement with the declaration of
      Helsinki. The protocol has been written and the study will be conducted according to The
      International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
      Human Use Harmonized Tripartite Guideline for Good Clinical Practice, issued by the European
      Union. The responsible Local Ethical Committee approval must be obtained before starting the
      trial. A copy of the patient informed consent form must be submitted to the appropriate
      authority or committee, together with the protocol for written approval. Written approval of
      the protocol and informed consent by the responsible and appropriate authority or committee
      must be obtained prior to recruitment of patients to the study.
observational model: Cohort
time perspective: Prospective
measure: Cytomegalovirus infection
time frame: 6 months from transplant
description: incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
measure: Cytomegalovirus disease
time frame: 6 months from transplant
description: incidence of Cytomegalovirus after allogeneic haematopoietic stem cell transplantation
measure: Herpesvirus human 6 infection
time frame: 6 months from transplant
description: incidence of human 6 infection after allogeneic haematopoietic stem cell transplantation
measure: Herpesvirus human 6 disease
time frame: 6 months from transplant
description: incidence of human 6 disease after allogeneic haematopoietic stem cell transplantation
measure: Virus Epstein-Barr infection
time frame: 6 months from transplant
description: incidence of Virus Epstein-Barr infections after allogeneic haematopoietic stem cell transplantation
measure: Virus Epstein-Barr disease
time frame: 6 months from transplant
description: incidence of Virus Epstein-Barr disease after allogeneic haematopoietic stem cell transplantation
measure: Overall Survival (OS)
time frame: These outcome measures will be assessed at 1 year from transplant
description: OS is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis
measure: Disease Free Survival (DFS)
time frame: These outcome measures will be assessed at 1 year from transplant
description: DFS is defined as the probability of being alive free of disease at any point in time.
measure: Transplant Related Mortality (TRM)
time frame: These outcome measures will be assessed at 1 year from transplant
description: TRM was defined as death due to any transplantation-related cause other than disease
measure: Relapse risk (RR)
time frame: These outcome measures will be assessed at 1 year from transplant
description: RR or risk ratio is the ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.
measure: Acute Graft-versus-Host Disease
time frame: These outcome measures will be assessed at 100 days from transplant
description: cumulative incidence of acute GvHD (grade II-IV)
measure: chronic graft-versus-host disease
time frame: These outcome measures will be assessed at 1 year from transplant
description: cumulative incidence and severity of chronic graft-versus-host disease
arm group label: Patients with hematological disease
description: Adult and children allogenic Hematopoietic stem cell transplantation recipients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Corrado Girmenia
role: Principal Investigator
affiliation: Azienda Policlinico Umberto I
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country: Italy
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Viremia
mesh term: Herpesviridae Infections
mesh term: Hematologic Diseases