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/NCT06013683</url>
    </required_header>
    <id_info>
      <org_study_id>SZ-SM01</org_study_id>
      <nct_id>NCT06013683</nct_id>
    </id_info>
    <brief_title>A Registry for Patients With Systemic Mastocytosis in China</brief_title>
    <official_title>Mastocvtosis Collaborative Network of China: A Registry for Patients With Systemic Mastocytosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Soochow University</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>
        The Registry for Patients With Systemic Mastocytosis in China is a voluntary, observational&#xD;
        database that will capture demographic, socioeconomic, and disease information with systemic&#xD;
        mastocytosis. No experimental intervention is involved.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Systemic Mastocytosis (SM) is an extremely rare and heterogeneous spectrum of diseases&#xD;
        characterized by the buildup of genetically altered mast cells in bone marrow sections and/or&#xD;
        other extracutaneous organ(s). SM has not been given enough attention in China at present,&#xD;
        and the epidemiological data in China are not clear. To understand the epidemiological&#xD;
        characteristics and distribution patterns of SM patients in China. To establish a China-wide&#xD;
        database platform for registering SM patients and to develop uniform registration standards&#xD;
        and processes; to register SM patients who meet the enrollment criteria nationwide through a&#xD;
        multicenter collaborative approach and to collect information on their baseline data,&#xD;
        clinical manifestations, laboratory tests, treatment regimens, and follow-up results; to&#xD;
        perform quality control and data cleansing on the information collected in the registration&#xD;
        database, as well as to perform descriptive and inferential statistical analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year)</measure>
      <time_frame>at 2 year</time_frame>
      <description>Evaluation of the morbidity rate over 2 years of Systemic Mastocytosis and its subtypes including Bone marrow mastocytosis (BMM), Indolent SM, Smoldering SM, Aggressive SM, SM with an associated hematologic neoplasm and Mast cell leukemia. (cases per 1,000 individuals per year)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Demographic characteristics of Systemic Mastocytosis</measure>
      <time_frame>at 2 year</time_frame>
      <description>The median age of Systemic Mastocytosis patients (year-old);&#xD;
  The sex distribution of Systemic Mastocytosis patients (M/F ratio[0-1]);&#xD;
  The ECOG score of Systemic Mastocytosis patients (score[0-5]);&#xD;
  The geographic distribution of Systemic Mastocytosis patients (% per province[0-100]);</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematological characteristics of Systemic Mastocytosis</measure>
      <time_frame>at 2 year</time_frame>
      <description>The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%);&#xD;
  The proliferative degree in sections of BM (%);&#xD;
  The ratio of mast cells in BM smear and FCM (%);&#xD;
  The ratio of expression of CD25, CD2, and CD30 in FCM (%);&#xD;
  The serum tryptase level(%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nonhematological characteristics of Systemic Mastocytosis</measure>
      <time_frame>at 2 year</time_frame>
      <description>The incidence of extramedullary organ infiltration including skin, bone and other organs (%);&#xD;
  The incidence of enlarged liver (%);&#xD;
  The incidence of enlarged spleen (%);&#xD;
  The incidence of enlarged lymphnodes (%);&#xD;
  The incidence of hypoproteinemia and loss weight (%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Responses to therapy of Systemic Mastocytosis</measure>
      <time_frame>at 2 year</time_frame>
      <description>The rate of eligible complete remission (CR) patients(%);&#xD;
  The rate of eligible partial remission (PR) patients(%);&#xD;
  The rate of eligible clincal improvement (CI) patients(%);&#xD;
  The rate of eligible stable disease (SD) patients(%);&#xD;
  The rate of eligible progressive disease (PD) patients(%);&#xD;
  The rate of eligible loss of reponse (LOR) patients(%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival Distribution of Systemic Mastocytosis</measure>
      <time_frame>at 2 year</time_frame>
      <description>Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death;&#xD;
  Event-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Systemic Mastocytoses</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with a diagnosis of systemic mastocytosis according to World Health Organization&#xD;
          (WHO) classification, including subtypes of SM, who is willing and able to provide written&#xD;
          online informed consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Any patient with a diagnosis of systemic mastocytosis according to World Health&#xD;
          Organization (WHO) classification, including subtypes of SM, who is willing and able to&#xD;
          provide written online informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suning Chen, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suning Chen, Professor</last_name>
      <phone>+86-13814881746</phone>
      <email>chensuning@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Suning Chen</last_name>
        <phone>+8613814881746</phone>
        <email>chensuning@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Soochow University</investigator_affiliation>
      <investigator_full_name>Chen Suning</investigator_full_name>
      <investigator_title>Director, Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mastocytosis</mesh_term>
      <mesh_term>Mastocytosis, Systemic</mesh_term>
    </condition_browse>
    <!-- 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/NCT06013683
  org study id: SZ-SM01
  nct id: NCT06013683
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The Registry for Patients With Systemic Mastocytosis in China is a voluntary, observational
        database that will capture demographic, socioeconomic, and disease information with systemic
        mastocytosis. No experimental intervention is involved.
  Systemic Mastocytosis (SM) is an extremely rare and heterogeneous spectrum of diseases
        characterized by the buildup of genetically altered mast cells in bone marrow sections and/or
        other extracutaneous organ(s). SM has not been given enough attention in China at present,
        and the epidemiological data in China are not clear. To understand the epidemiological
        characteristics and distribution patterns of SM patients in China. To establish a China-wide
        database platform for registering SM patients and to develop uniform registration standards
        and processes; to register SM patients who meet the enrollment criteria nationwide through a
        multicenter collaborative approach and to collect information on their baseline data,
        clinical manifestations, laboratory tests, treatment regimens, and follow-up results; to
        perform quality control and data cleansing on the information collected in the registration
        database, as well as to perform descriptive and inferential statistical analyses.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: The morbidity rate over 2 years ofSystemic Mastocytosis and its subtypes (cases per 1,000 individuals per year)
  time frame: at 2 year
  description: Evaluation of the morbidity rate over 2 years of Systemic Mastocytosis and its subtypes including Bone marrow mastocytosis (BMM), Indolent SM, Smoldering SM, Aggressive SM, SM with an associated hematologic neoplasm and Mast cell leukemia. (cases per 1,000 individuals per year)
  measure: Demographic characteristics of Systemic Mastocytosis
  time frame: at 2 year
  description: The median age of Systemic Mastocytosis patients (year-old);
  The sex distribution of Systemic Mastocytosis patients (M/F ratio[0-1]);
  The ECOG score of Systemic Mastocytosis patients (score[0-5]);
  The geographic distribution of Systemic Mastocytosis patients (% per province[0-100]);
  measure: Hematological characteristics of Systemic Mastocytosis
  time frame: at 2 year
  description: The neutrophils, eosinophils, basophils, and mast cells in WBC classification (%);
  The proliferative degree in sections of BM (%);
  The ratio of mast cells in BM smear and FCM (%);
  The ratio of expression of CD25, CD2, and CD30 in FCM (%);
  The serum tryptase level(%).
  measure: Nonhematological characteristics of Systemic Mastocytosis
  time frame: at 2 year
  description: The incidence of extramedullary organ infiltration including skin, bone and other organs (%);
  The incidence of enlarged liver (%);
  The incidence of enlarged spleen (%);
  The incidence of enlarged lymphnodes (%);
  The incidence of hypoproteinemia and loss weight (%).
  measure: Responses to therapy of Systemic Mastocytosis
  time frame: at 2 year
  description: The rate of eligible complete remission (CR) patients(%);
  The rate of eligible partial remission (PR) patients(%);
  The rate of eligible clincal improvement (CI) patients(%);
  The rate of eligible stable disease (SD) patients(%);
  The rate of eligible progressive disease (PD) patients(%);
  The rate of eligible loss of reponse (LOR) patients(%).
  measure: Survival Distribution of Systemic Mastocytosis
  time frame: at 2 year
  description: Overall survival (months): Measured the time from enrollment to the date of the last follow-up or death;
  Event-free survival (months): Measured the time from the date of attaining CR1 until the first relapse, death, or the final follow-up day.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Suning Chen, Professor
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
  last name: Suning Chen, Professor
  phone: +86-13814881746
  email: chensuning@sina.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital of Soochow University
  investigator full name: Chen Suning
  investigator title: Director, Clinical Professor
  mesh term: Mastocytosis
  mesh term: Mastocytosis, Systemic