<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/NCT01693952</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00322-41</org_study_id>
    <secondary_id>2012-08</secondary_id>
    <nct_id>NCT01693952</nct_id>
  </id_info>
  <brief_title>Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach</brief_title>
  <official_title>Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment of cancer, and more particularly of haematological malignancies, partly relies on&#xD;
      chemotherapy. Most therapeutic regimens display various toxicities, one of the most common&#xD;
      being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia&#xD;
      can be overcome by haematological growth factors and transfusion, one of the most severe&#xD;
      life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite&#xD;
      the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major&#xD;
      limitation in chemotherapy which is responsible for the majority of treatment-related&#xD;
      morbidity and mortality and for prolonged hospitalisation.&#xD;
&#xD;
      In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic&#xD;
      patients. While the occurence of neutropenia and sepsis is often unpredictable and thus&#xD;
      difficult to study in a prospective way, stem cell transplantation represents a quite&#xD;
      convenient model to study such a question. Autologous stem cell transplantation indications&#xD;
      in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly,&#xD;
      after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by&#xD;
      cytapheresis and frozen. When the patient has reached complete remission by conventional&#xD;
      chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called&#xD;
      &quot;conditioning regimen&quot;). The &quot;conditioning regimen&quot; targeted to have high antitumoral&#xD;
      activity leads to a &quot;cytokine storm&quot; resulting in a &quot;programmed inflammation&quot;. 36 hours after&#xD;
      the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the&#xD;
      patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days,&#xD;
      until graft becomes &quot;functional&quot;. Thus, the timing and duration of neutropenia are very&#xD;
      homogeneous. During neutropenia, fever and sepsis are very frequent (&gt;80% patients), thus,&#xD;
      most patient will be informative regarding sepsis, and there is an easy possibility of&#xD;
      biological sampling before&quot; programmed inflammation&quot; (due to conditioning regimen), after&#xD;
      inflammation before sepsis, then during and after the sepsis. Since the patient is&#xD;
      hospitalized, the kinetic monitoring is quite easy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood samples</measure>
    <time_frame>3 YEARS</time_frame>
    <description>transcriptomic profile identification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood samples</measure>
    <time_frame>3 YEARS</time_frame>
    <description>the observed profile in patients developing fever and sepsis in comparison with patients not developing such complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood samples</measure>
    <time_frame>3 YEARS</time_frame>
    <description>the prediction, for each patient, a transcriptomic signature linked to a higher risk developing a sepsis.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Sepsis in Neutropenic Patients</condition>
  <arm_group>
    <arm_group_label>blood samples</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood draw</intervention_name>
    <arm_group_label>blood samples</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the criteria required to be candidate in an ASCH in our service(department) (age 18 -&#xD;
             66 years, myélome in 1 ° in reply partial line or lymphoma or complete answer after&#xD;
             one 2 ° line, absence of preliminary visceral failure).&#xD;
&#xD;
        Informed, willing patients and having given their agreement in writing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient&#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>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LAURE FARNAULT</last_name>
    <email>laure.farnault@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>laure farnault</last_name>
      <phone>04 91 38 41 53</phone>
      <email>laure.farnault@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>laure farnault</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>May 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>August 29, 2014</last_update_submitted>
  <last_update_submitted_qc>August 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</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>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT01693952
org study id: 2012-A00322-41
secondary id: 2012-08
nct id: NCT01693952
lead sponsor: 
has dmc: No
Treatment of cancer, and more particularly of haematological malignancies, partly relies on
      chemotherapy. Most therapeutic regimens display various toxicities, one of the most common
      being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia
      can be overcome by haematological growth factors and transfusion, one of the most severe
      life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite
      the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major
      limitation in chemotherapy which is responsible for the majority of treatment-related
      morbidity and mortality and for prolonged hospitalisation.

      In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic
      patients. While the occurence of neutropenia and sepsis is often unpredictable and thus
      difficult to study in a prospective way, stem cell transplantation represents a quite
      convenient model to study such a question. Autologous stem cell transplantation indications
      in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly,
      after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by
      cytapheresis and frozen. When the patient has reached complete remission by conventional
      chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called
      "conditioning regimen"). The "conditioning regimen" targeted to have high antitumoral
      activity leads to a "cytokine storm" resulting in a "programmed inflammation". 36 hours after
      the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the
      patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days,
      until graft becomes "functional". Thus, the timing and duration of neutropenia are very
      homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus,
      most patient will be informative regarding sepsis, and there is an easy possibility of
      biological sampling before" programmed inflammation" (due to conditioning regimen), after
      inflammation before sepsis, then during and after the sepsis. Since the patient is
      hospitalized, the kinetic monitoring is quite easy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: blood samples
time frame: 3 YEARS
description: transcriptomic profile identification
measure: blood samples
time frame: 3 YEARS
description: the observed profile in patients developing fever and sepsis in comparison with patients not developing such complications
measure: blood samples
time frame: 3 YEARS
description: the prediction, for each patient, a transcriptomic signature linked to a higher risk developing a sepsis.
arm group label: blood samples
arm group type: Experimental
intervention type: Biological
intervention name: blood draw
arm group label: blood samples
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique hôpitaux de Marseille
last name: LAURE FARNAULT
email: laure.farnault@ap-hm.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia