xml: <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/NCT05969821</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221121</org_study_id>
      <nct_id>NCT05969821</nct_id>
    </id_info>
    <brief_title>Clonal Hematopoiesis of Immunological Significance</brief_title>
    <acronym>CHIS</acronym>
    <official_title>National Cohort of Patients With Dysimmune Manifestations With or Without Clonal Hematopoiesis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sorbonne University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        Ambispective, national, multicenter observational cohort study aimed at characterizing the&#xD;
        satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1&#xD;
        enzyme, X-linked, Autoinflammatory and Somatic) syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The clinical spectrum of dysimmune manifestations associated with blood diseases is wide. The&#xD;
        pathophysiology of these manifestations is not well understood and their management is poorly&#xD;
        codified. This observational cohort aims to list the different clinical pictures, the&#xD;
        therapeutic management and the prognosis of patients according to the type of dysimmune&#xD;
        manifestations and the type of hemopathy. We wish to have an inventory of the demographic,&#xD;
        genetic, clinical and evolutionary data of patients with an inflammatory manifestation&#xD;
        associated or not with a myeloid or lymphoid hemopathy. This will make it possible to&#xD;
        establish quantitative data on the morbidity and mortality of these rare diseases and to&#xD;
        propose therapeutic trials for the most serious patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2043</completion_date>
    <primary_completion_date type="Anticipated">September 2043</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>20 Years</target_duration>
    <primary_outcome>
      <measure>Incidence of dysimmune manifestations associated with hematological disorders</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of new cases</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VEXAS syndrome</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with VEXAS syndrome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dysimmune manifestations other than VEXAS syndrome</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with dysimmune manifestations other than VEXAS syndrome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Myeloid hemopathy</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with myeloid hemopathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lymphoid hemopathy</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with lymphoid hemopathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clonal hematopoiesis of undeterminate potential</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with clonal hematopoiesis of undeterminate potential</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with skin involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Musculoskeletal involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with musculoskeletal involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ocular involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with ocular involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vascular involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with vascular involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with neurological involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digestive system involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with digestive system involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with cardiac involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with pulmonary involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renal involvement</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients with renal involvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Therapeutic interventions received</measure>
      <time_frame>10 years</time_frame>
      <description>Type and duration of therapeutic interventions received</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression to acute myeloid leukemia</measure>
      <time_frame>10 years</time_frame>
      <description>Number of patients who progressed to acute myeloid leukemia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall mortality</measure>
      <time_frame>10 years</time_frame>
      <description>Overall mortality rate from all causes</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Immune System Diseases</condition>
    <condition>Autoimmune Diseases</condition>
    <condition>Inflammation</condition>
    <condition>Autoinflammatory Diseases</condition>
    <condition>Vexas Syndrome</condition>
    <condition>Hematopoiesis Clonal</condition>
    <condition>Clonal Hematopoiesis of Indeterminate Potential</condition>
    <condition>Hematologic Diseases</condition>
    <condition>Myelodysplastic-Myeloproliferative Diseases</condition>
    <condition>Leukemia Myelomonocytic Chronic</condition>
    <condition>Myelodysplastic Syndromes</condition>
    <condition>Myeloproliferative Disorders</condition>
    <condition>Lymphoproliferative Disorders</condition>
    <condition>Lymphoma</condition>
    <condition>Leukemia</condition>
    <condition>Monoclonal Gammopathy of Undetermined Significance</condition>
    <arm_group>
      <arm_group_label>Dysimmune manifestations with or without clonal hematopoiesis</arm_group_label>
      <description>Dysimmune manifestations with or without clonal hematopoiesis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>observational cohort study</intervention_name>
      <description>observational cohort study</description>
      <arm_group_label>Dysimmune manifestations with or without clonal hematopoiesis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The research concerns :&#xD;
  &#xD;
            -  patients whose inflammatory disease without or with haemopathy is already known when&#xD;
               the cohort is set up, and for whom data will be collected retrospectively and then&#xD;
               prospectively&#xD;
  &#xD;
            -  incident cases identified after the cohort was set up.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;=18 years old&#xD;
  &#xD;
            -  Confirmed dysimmune manifestations: clinical or biological abnormality or systemic&#xD;
               disease&#xD;
  &#xD;
            -  Presence or absence of myeloid or lymphoid blood disease according to World Health&#xD;
               Organization (WHO) classification&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons benefiting from special protection: adults under guardianship and curatorship;&#xD;
               people hospitalized without their consent and not protected by law; persons deprived&#xD;
               of liberty.&#xD;
  &#xD;
            -  Persons not affiliated to the social security system&#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>Arsene MEKINIAN, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Service de médecine interne, Hôpital Saint Antoine, APHP, Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arsene MEKINIAN, MD PhD</last_name>
      <phone>+33149282392</phone>
      <email>arsene.mekinian@aphp.fr</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Inflammation</keyword>
    <keyword>Autoinflammatory Diseases</keyword>
    <keyword>Vexas syndrome</keyword>
    <keyword>Autoimmune Diseases</keyword>
    <keyword>Clonal Hematopoiesis of Indeterminate Potential</keyword>
    <keyword>Myelodysplastic-Myeloproliferative Diseases</keyword>
    <keyword>Lymphoproliferative Disorders</keyword>
    <keyword>Monoclonal Gammopathy of Undetermined Significance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Myelodysplastic Syndromes</mesh_term>
      <mesh_term>Lymphoproliferative Disorders</mesh_term>
      <mesh_term>Hematologic Diseases</mesh_term>
      <mesh_term>Myeloproliferative Disorders</mesh_term>
      <mesh_term>Paraproteinemias</mesh_term>
      <mesh_term>Monoclonal Gammopathy of Undetermined Significance</mesh_term>
      <mesh_term>Myelodysplastic-Myeloproliferative Diseases</mesh_term>
      <mesh_term>Autoimmune Diseases</mesh_term>
      <mesh_term>Immune System Diseases</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969821
  org study id: APHP221121
  nct id: NCT05969821
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Ambispective, national, multicenter observational cohort study aimed at characterizing the
        satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1
        enzyme, X-linked, Autoinflammatory and Somatic) syndrome.
  The clinical spectrum of dysimmune manifestations associated with blood diseases is wide. The
        pathophysiology of these manifestations is not well understood and their management is poorly
        codified. This observational cohort aims to list the different clinical pictures, the
        therapeutic management and the prognosis of patients according to the type of dysimmune
        manifestations and the type of hemopathy. We wish to have an inventory of the demographic,
        genetic, clinical and evolutionary data of patients with an inflammatory manifestation
        associated or not with a myeloid or lymphoid hemopathy. This will make it possible to
        establish quantitative data on the morbidity and mortality of these rare diseases and to
        propose therapeutic trials for the most serious patients.
  observational model: Cohort
  time perspective: Other
  measure: Incidence of dysimmune manifestations associated with hematological disorders
  time frame: Baseline
  description: Number of new cases
  measure: VEXAS syndrome
  time frame: 10 years
  description: Number of patients with VEXAS syndrome
  measure: Dysimmune manifestations other than VEXAS syndrome
  time frame: 10 years
  description: Number of patients with dysimmune manifestations other than VEXAS syndrome
  measure: Myeloid hemopathy
  time frame: 10 years
  description: Number of patients with myeloid hemopathy
  measure: Lymphoid hemopathy
  time frame: 10 years
  description: Number of patients with lymphoid hemopathy
  measure: Clonal hematopoiesis of undeterminate potential
  time frame: 10 years
  description: Number of patients with clonal hematopoiesis of undeterminate potential
  measure: Skin involvement
  time frame: 10 years
  description: Number of patients with skin involvement
  measure: Musculoskeletal involvement
  time frame: 10 years
  description: Number of patients with musculoskeletal involvement
  measure: Ocular involvement
  time frame: 10 years
  description: Number of patients with ocular involvement
  measure: Vascular involvement
  time frame: 10 years
  description: Number of patients with vascular involvement
  measure: Neurological involvement
  time frame: 10 years
  description: Number of patients with neurological involvement
  measure: Digestive system involvement
  time frame: 10 years
  description: Number of patients with digestive system involvement
  measure: Cardiac involvement
  time frame: 10 years
  description: Number of patients with cardiac involvement
  measure: Pulmonary involvement
  time frame: 10 years
  description: Number of patients with pulmonary involvement
  measure: Renal involvement
  time frame: 10 years
  description: Number of patients with renal involvement
  measure: Therapeutic interventions received
  time frame: 10 years
  description: Type and duration of therapeutic interventions received
  measure: Progression to acute myeloid leukemia
  time frame: 10 years
  description: Number of patients who progressed to acute myeloid leukemia
  measure: Overall mortality
  time frame: 10 years
  description: Overall mortality rate from all causes
  arm group label: Dysimmune manifestations with or without clonal hematopoiesis
  description: Dysimmune manifestations with or without clonal hematopoiesis
  intervention type: Other
  intervention name: observational cohort study
  description: observational cohort study
  arm group label: Dysimmune manifestations with or without clonal hematopoiesis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Arsene MEKINIAN, MD PhD
  role: Principal Investigator
  affiliation: Service de médecine interne, Hôpital Saint Antoine, APHP, Paris
  last name: Arsene MEKINIAN, MD PhD
  phone: +33149282392
  email: arsene.mekinian@aphp.fr
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Myelodysplastic Syndromes
  mesh term: Lymphoproliferative Disorders
  mesh term: Hematologic Diseases
  mesh term: Myeloproliferative Disorders
  mesh term: Paraproteinemias
  mesh term: Monoclonal Gammopathy of Undetermined Significance
  mesh term: Myelodysplastic-Myeloproliferative Diseases
  mesh term: Autoimmune Diseases
  mesh term: Immune System Diseases
  mesh term: Syndrome
  mesh term: Inflammation
  sharing ipd: No