<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/NCT03009708</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1101</org_study_id>
    <secondary_id>2016-A01833-48</secondary_id>
    <nct_id>NCT03009708</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen</brief_title>
  <acronym>FIPALLOC</acronym>
  <official_title>Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Cancérologie de la Loire</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>
      Traditionally known for their role in haemostasis, platelets have also an immune role.&#xD;
&#xD;
      Platelets play a key role in immune mediator secretion, and interact with innate and adaptive&#xD;
      immune cells, contributing to the fight against pathogens, as viruses.&#xD;
&#xD;
      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of&#xD;
      the induced immune depression. Platelets activation for patients is not determined during the&#xD;
      post-graft period, and platelet induced inflammation following a CMV infection is not&#xD;
      described.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The descriptive present study will determine if platelet activation is altered during the&#xD;
      post-graft follow-up (day 30 to 90).&#xD;
&#xD;
      The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus)&#xD;
      antigen.&#xD;
&#xD;
      The study will also focus on inflammatory response variation, focusing on the cytokines&#xD;
      release during the same post-graft follow-up (spontaneously and after CMV antigen&#xD;
      stimulation).&#xD;
&#xD;
      This preliminary study could lead to a better understanding of the immune-modulator role of&#xD;
      inflammation, controlled by the platelets, particularly in the initiation of the&#xD;
      Graft-versus-host disease in this kind of population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">November 6, 2017</completion_date>
  <primary_completion_date type="Actual">September 12, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In vitro spontaneous CD62P (P-selectin) expression level</measure>
    <time_frame>90 Days</time_frame>
    <description>In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In vitro spontaneous CD63 (membrane protein) expression level</measure>
    <time_frame>90 Days</time_frame>
    <description>In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation</measure>
    <time_frame>90 Days</time_frame>
    <description>In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation</measure>
    <time_frame>90 Days</time_frame>
    <description>In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of in vitro spontaneous platelet activation</measure>
    <time_frame>90 Days</time_frame>
    <description>Level of in vitro spontaneous platelet activation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) spontaneous expression level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of in vitro platelet activation after a CMV antigen stimulation</measure>
    <time_frame>90 Days</time_frame>
    <description>Level of in vitro platelet activation after a CMV antigen stimulation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) expression level.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Allograft</condition>
  <arm_group>
    <arm_group_label>Allograft patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Allograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.</description>
    <arm_group_label>Allograft patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who received an allogeneic haematopoietic stem cell transplant for less than&#xD;
             2 months for any indication ;&#xD;
&#xD;
          -  Platelets &gt; 20 G / L (Giga per Litre) for at least 7 days without transfusion support&#xD;
             ;&#xD;
&#xD;
          -  Patients affiliated to a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving antiplatelet therapy ;&#xD;
&#xD;
          -  Major protected or unable to give consent ;&#xD;
&#xD;
          -  Pregnant women ;&#xD;
&#xD;
          -  Vulnerable persons defined by French legislation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CORNILLON Jérôme, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie Lucien Neuwirth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest en Jarez</city>
        <zip>42 270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allograft</keyword>
  <keyword>Cytomegalovirus</keyword>
  <keyword>Platelets</keyword>
  <keyword>Hematopoietic stem cells</keyword>
  <keyword>Graft Versus Host Disease (GVH)</keyword>
  <keyword>Hemostasis</keyword>
  <keyword>Adaptive immunity</keyword>
  <keyword>Innate immunity</keyword>
  <keyword>Post graft follow up</keyword>
  <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/NCT03009708
org study id: 2016-1101
secondary id: 2016-A01833-48
nct id: NCT03009708
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditionally known for their role in haemostasis, platelets have also an immune role.

      Platelets play a key role in immune mediator secretion, and interact with innate and adaptive
      immune cells, contributing to the fight against pathogens, as viruses.

      Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of
      the induced immune depression. Platelets activation for patients is not determined during the
      post-graft period, and platelet induced inflammation following a CMV infection is not
      described.
The descriptive present study will determine if platelet activation is altered during the
      post-graft follow-up (day 30 to 90).

      The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus)
      antigen.

      The study will also focus on inflammatory response variation, focusing on the cytokines
      release during the same post-graft follow-up (spontaneously and after CMV antigen
      stimulation).

      This preliminary study could lead to a better understanding of the immune-modulator role of
      inflammation, controlled by the platelets, particularly in the initiation of the
      Graft-versus-host disease in this kind of population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: In vitro spontaneous CD62P (P-selectin) expression level
time frame: 90 Days
description: In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
measure: In vitro spontaneous CD63 (membrane protein) expression level
time frame: 90 Days
description: In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
measure: In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
time frame: 90 Days
description: In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
measure: In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
time frame: 90 Days
description: In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
measure: Level of in vitro spontaneous platelet activation
time frame: 90 Days
description: Level of in vitro spontaneous platelet activation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) spontaneous expression level.
measure: Level of in vitro platelet activation after a CMV antigen stimulation
time frame: 90 Days
description: Level of in vitro platelet activation after a CMV antigen stimulation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) expression level.
arm group label: Allograft patients
arm group type: Experimental
description: Allograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples.
intervention type: Other
intervention name: Blood samples
description: Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.
arm group label: Allograft patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: CORNILLON Jérôme, PhD
role: Principal Investigator
affiliation: Institut de Cancérologie Lucien Neuwirth
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No