<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/NCT04438278</url>
  </required_header>
  <id_info>
    <org_study_id>APHP190826</org_study_id>
    <nct_id>NCT04438278</nct_id>
  </id_info>
  <brief_title>Profile Fecal Analysis of Neutropenic Enterocolitis</brief_title>
  <acronym>PROFANE</acronym>
  <official_title>Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, single-center, cohort study to allow collecting observations of patients&#xD;
      receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting&#xD;
      biological samples(including fecal samples for microbiota analyses, and metagenomic profiling&#xD;
      in blood samples) and clinical outcomes (notably the occurrence of neutropenic&#xD;
      enterocolitis), with a nested case-control analysis comparing patients with or without&#xD;
      neutropenic enterocolitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Shannon index of α-diversity</measure>
    <time_frame>At day 1, before chemotherapy initiation</time_frame>
    <description>Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal microbiota's profile</measure>
    <time_frame>At day 14</time_frame>
    <description>Taxonomic identification in shotgun metagenomic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit (ICU) - mortality</measure>
    <time_frame>60 days</time_frame>
    <description>Death while hospitalized in the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital - mortality</measure>
    <time_frame>60 days</time_frame>
    <description>Death while hospitalized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Death within 1 year of inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of any local neutropenic enterocolitis complications</measure>
    <time_frame>60 days</time_frame>
    <description>Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis</measure>
    <time_frame>60 days</time_frame>
    <description>Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of malnutrition in patients with severe neutropenic enterocolitis</measure>
    <time_frame>60 days</time_frame>
    <description>Malnutrition defined by the European Society of Clinical nutrition and Metabolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biodiversity in microbiota</measure>
    <time_frame>Day 1, day 14, day 28, day 42</time_frame>
    <description>Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-blood metatranscriptomic profile evolution</measure>
    <time_frame>Day 1, day 14, day 28, day 42</time_frame>
    <description>Identification of clusters of gene expression</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Neutropenic Enterocolitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient&gt;= 18 years old;&#xD;
&#xD;
          -  cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (&gt;20% myeloid blasts);&#xD;
&#xD;
          -  eligible for intensive chemotherapy (no severe co-morbidity);&#xD;
&#xD;
          -  not having received any prior chemotherapy;&#xD;
&#xD;
          -  affiliation to the national social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute promyelocytic leukemia (AML 3);&#xD;
&#xD;
          -  inability to understand the nature of investigations or to give informed&#xD;
             non-opposition;&#xD;
&#xD;
          -  person subject to a legal protection measure.&#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_contact>
    <last_name>Lara Zafrani, MD PhD</last_name>
    <phone>+33 1 42 49 49 49</phone>
    <email>lara.zafrani@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>AP-HP Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</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>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Neutropenic</mesh_term>
  </condition_browse>
  <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/NCT04438278
org study id: APHP190826
nct id: NCT04438278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, single-center, cohort study to allow collecting observations of patients
      receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting
      biological samples(including fecal samples for microbiota analyses, and metagenomic profiling
      in blood samples) and clinical outcomes (notably the occurrence of neutropenic
      enterocolitis), with a nested case-control analysis comparing patients with or without
      neutropenic enterocolitis
observational model: Other
time perspective: Prospective
measure: Shannon index of α-diversity
time frame: At day 1, before chemotherapy initiation
description: Shannon index of α-diversity assessed by shotgun metagenomic analysis of the stool
measure: Fecal microbiota's profile
time frame: At day 14
description: Taxonomic identification in shotgun metagenomic
measure: Intensive Care Unit (ICU) - mortality
time frame: 60 days
description: Death while hospitalized in the intensive care unit
measure: Hospital - mortality
time frame: 60 days
description: Death while hospitalized
measure: 1-year mortality
time frame: 1 year
description: Death within 1 year of inclusion
measure: Occurrence of any local neutropenic enterocolitis complications
time frame: 60 days
description: Local neutropenic enterocolitis complications defined as perforation or digestive hemorrhage or abscess
measure: Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis
time frame: 60 days
description: Microbiologically documented infections defined as pneumonia, invasive device infections, urinary tract infections, digestive or neuro-meningitis infections
measure: Occurrence of malnutrition in patients with severe neutropenic enterocolitis
time frame: 60 days
description: Malnutrition defined by the European Society of Clinical nutrition and Metabolism
measure: Biodiversity in microbiota
time frame: Day 1, day 14, day 28, day 42
description: Analysis of alpha and beta-diversity in fecal samples from day 0 to day 60
measure: Whole-blood metatranscriptomic profile evolution
time frame: Day 1, day 14, day 28, day 42
description: Identification of clusters of gene expression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lara Zafrani, MD PhD
phone: +33 1 42 49 49 49
email: lara.zafrani@aphp.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Enterocolitis
mesh term: Enterocolitis, Neutropenic
sharing ipd: No