<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/NCT02254798</url>
  </required_header>
  <id_info>
    <org_study_id>NI13015 PLASMA-INCA</org_study_id>
    <nct_id>NCT02254798</nct_id>
  </id_info>
  <brief_title>Biomarkers for Acute Graft-versus-host Disease</brief_title>
  <acronym>PLASMA-INCA</acronym>
  <official_title>Diagnostic and Prognostic Biomarkers for Acute Graft-versus-host Disease: a Prospective Single Centre Biological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Validation of already described biomarkers on acute GVHD prediction and severity Fecal&#xD;
      calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha,&#xD;
      HGF&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description of the project: The main objective of this prospective biological single center&#xD;
      study (non interventional) is to identify non invasive biomarkers able to diagnose acute GVHD&#xD;
      and/or predict outcome of patients with acute GVHD. The primary objective of the study is&#xD;
      double: (1): to evaluate markers as diagnostic markers of GVHD (2): to evaluate the potential&#xD;
      of the markers as risk factor for steroid-refractory acute GVHD occurrence. Secondary&#xD;
      objectives are: -to evaluate the markers as risk factors for GVHD -to evaluate the potential&#xD;
      of these markers as prognostic factors of 6-month non-relapse mortality in patients with&#xD;
      acute GVHD-to evaluate the additional value of the biomarkers to predict GVHD or&#xD;
      steroid-refractory GVHD as compared to other known and routinely used risk factors (clinical&#xD;
      grading system, performance status, albuminemia...). Stools and blood will be on day 7, 14,&#xD;
      21, 28 after transplantation and the first day of digestive GVHD. Management of patients will&#xD;
      not differ from the usual care. Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a,&#xD;
      IL-8, Elafin, TNFaR1, IL-2R alpha, HGF will be measured at each points by ELISA tests. 315&#xD;
      patients would be sufficient to estimate the area under the ROC curve with a half-width of&#xD;
      the 99% confidence interval of 0.05, assuming 60% of patients would develop acute GVHD, and&#xD;
      normally distributed markers. The diagnosis and prognosis values will be analyzed separately.&#xD;
&#xD;
      Expected results: If some biomarkers are found significantly associated with diagnosis or&#xD;
      prognosis of acute GVHD, they will be compared with the current clinical, biological and&#xD;
      histological markers. Indeed, these markers have a clinical potential impact only if they&#xD;
      give similar or better information than routine currently available markers, ie: clinical&#xD;
      GVHD grading system, performance status, gut endoscopy and histology. The non-invasivity of&#xD;
      these biomarkers should also be taken into account (in comparison to histology).&#xD;
&#xD;
      Identification of diagnostic markers will avoid useless treatment with high dose&#xD;
      corticosteroids in patients without GVHD Identification of prognostic markers will comfort&#xD;
      the decision of a second-line treatment sooner than usually, ie: at GVHD onset. Indeed, the&#xD;
      onset of a second-line treatment after a steroid-refractory GVHD varies from 3 to 21 days&#xD;
      depending on clinical evolution of patients. If some prognostic markers are available at&#xD;
      diagnosis, delay in second-line treatment can be shortened and the patient can consequently&#xD;
      have an increased chance to response to an early treatment.&#xD;
&#xD;
      Identification of prognostic markers will also guide the corticosteroids decrease in patients&#xD;
      with good prognosis GVHD&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Number of patients with an Acute Graft-versus-Host disease</measure>
    <time_frame>The 6 first months after transplantation</time_frame>
    <description>Evaluation of fecal and plasmatic markers as diagnostic markers of GVHD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with an Acute Graft-versus-Host disease refractory to steroids</measure>
    <time_frame>14 days after acute graft-versus-host disease</time_frame>
    <description>to evaluate the potential of these markers as risk factors for steroid-refractory acute GVHD occurrence</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">315</enrollment>
  <condition>Acute GVH Disease</condition>
  <arm_group>
    <arm_group_label>Transplanted patients</arm_group_label>
    <description>No intervention Prospective registration of patients receiving an allogeneic hematopoietic stem cell transplant</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>this is a non interventional study</description>
    <arm_group_label>Transplanted patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample on day 7, 14, 21, 28 and at GVHD onset&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients receiving an allogeneic transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients receiving an allogeneic transplant&#xD;
&#xD;
          -  informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Robin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint-Louis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie Robin, MD, PhD</last_name>
    <phone>33142494724</phone>
    <email>marie.robin@sls.aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>marie-Hélène Schlageter, PHD</last_name>
    <email>marie-helene.schlageter@sls.aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Robin, MD, PhD</last_name>
      <email>marie.robin@sls.aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Robin</last_name>
      <email>marie.robin@sls.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Marie Robin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 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>Graft vs Host Disease</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/NCT02254798
org study id: NI13015 PLASMA-INCA
nct id: NCT02254798
lead sponsor: 
has dmc: No
Validation of already described biomarkers on acute GVHD prediction and severity Fecal
      calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha,
      HGF
Description of the project: The main objective of this prospective biological single center
      study (non interventional) is to identify non invasive biomarkers able to diagnose acute GVHD
      and/or predict outcome of patients with acute GVHD. The primary objective of the study is
      double: (1): to evaluate markers as diagnostic markers of GVHD (2): to evaluate the potential
      of the markers as risk factor for steroid-refractory acute GVHD occurrence. Secondary
      objectives are: -to evaluate the markers as risk factors for GVHD -to evaluate the potential
      of these markers as prognostic factors of 6-month non-relapse mortality in patients with
      acute GVHD-to evaluate the additional value of the biomarkers to predict GVHD or
      steroid-refractory GVHD as compared to other known and routinely used risk factors (clinical
      grading system, performance status, albuminemia...). Stools and blood will be on day 7, 14,
      21, 28 after transplantation and the first day of digestive GVHD. Management of patients will
      not differ from the usual care. Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a,
      IL-8, Elafin, TNFaR1, IL-2R alpha, HGF will be measured at each points by ELISA tests. 315
      patients would be sufficient to estimate the area under the ROC curve with a half-width of
      the 99% confidence interval of 0.05, assuming 60% of patients would develop acute GVHD, and
      normally distributed markers. The diagnosis and prognosis values will be analyzed separately.

      Expected results: If some biomarkers are found significantly associated with diagnosis or
      prognosis of acute GVHD, they will be compared with the current clinical, biological and
      histological markers. Indeed, these markers have a clinical potential impact only if they
      give similar or better information than routine currently available markers, ie: clinical
      GVHD grading system, performance status, gut endoscopy and histology. The non-invasivity of
      these biomarkers should also be taken into account (in comparison to histology).

      Identification of diagnostic markers will avoid useless treatment with high dose
      corticosteroids in patients without GVHD Identification of prognostic markers will comfort
      the decision of a second-line treatment sooner than usually, ie: at GVHD onset. Indeed, the
      onset of a second-line treatment after a steroid-refractory GVHD varies from 3 to 21 days
      depending on clinical evolution of patients. If some prognostic markers are available at
      diagnosis, delay in second-line treatment can be shortened and the patient can consequently
      have an increased chance to response to an early treatment.

      Identification of prognostic markers will also guide the corticosteroids decrease in patients
      with good prognosis GVHD
observational model: Cohort
time perspective: Prospective
measure: Number of patients with an Acute Graft-versus-Host disease
time frame: The 6 first months after transplantation
description: Evaluation of fecal and plasmatic markers as diagnostic markers of GVHD
measure: Number of patients with an Acute Graft-versus-Host disease refractory to steroids
time frame: 14 days after acute graft-versus-host disease
description: to evaluate the potential of these markers as risk factors for steroid-refractory acute GVHD occurrence
arm group label: Transplanted patients
description: No intervention Prospective registration of patients receiving an allogeneic hematopoietic stem cell transplant
intervention type: Other
intervention name: no intervention
description: this is a non interventional study
arm group label: Transplanted patients
blood sample on day 7, 14, 21, 28 and at GVHD onset
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marie Robin
role: Principal Investigator
affiliation: Hôpital Saint-Louis
last name: Marie Robin, MD, PhD
phone: 33142494724
email: marie.robin@sls.aphp.fr
last name: marie-Hélène Schlageter, PHD
email: marie-helene.schlageter@sls.aphp.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Graft vs Host Disease