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/NCT05965115</url>
    </required_header>
    <id_info>
      <org_study_id>CHAPERONE</org_study_id>
      <nct_id>NCT05965115</nct_id>
    </id_info>
    <brief_title>The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study</brief_title>
    <acronym>CHAPERONE</acronym>
    <official_title>The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of&#xD;
        Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of&#xD;
        screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with&#xD;
        multiple myeloma in China population, and establish a prospective cohort of individuals with&#xD;
        monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple&#xD;
        myeloma. We will study these patients as a means to identify risk factors for progression to&#xD;
        symptomatic multiple myeloma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The CHAPERONE study aims to assess the clinical significance of screening for monoclonal&#xD;
        gammopathy in first-degree relatives of patients with multiple myeloma in China.&#xD;
  &#xD;
        The main objectives it aims to answer are:&#xD;
  &#xD;
          -  Main research objectives: To study the prevalence of MGUS, the time of disease&#xD;
             progression, and its influencing factors in first-degree relatives of multiple myeloma&#xD;
             patients in China.&#xD;
  &#xD;
          -  Secondary study objective: To explore the clinical/genomic/epigenetic features,&#xD;
             survival, and quality of life of MGUS patients in first-degree relatives of multiple&#xD;
             myeloma patients in China.&#xD;
  &#xD;
        All participants will receive M-protein screening by serum electrophoresis. Individuals with&#xD;
        detected M-protein will undergo further diagnostic tests, and patients with MGUS will be&#xD;
        carefully assessed and followed up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">August 2035</completion_date>
    <primary_completion_date type="Anticipated">August 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives</measure>
      <time_frame>2 Years</time_frame>
      <description>The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to progression (TTP) from MGUS to overt multiple myeloma</measure>
      <time_frame>10 Years</time_frame>
      <description>The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival of MGUS patients</measure>
      <time_frame>10 Years</time_frame>
      <description>The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL) of MGUS patients</measure>
      <time_frame>10 Years</time_frame>
      <description>QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Multiple Myeloma</condition>
    <condition>Monoclonal Gammopathy of Undetermined Significance</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Sample of Blood</intervention_name>
      <description>All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The first-degree relatives of patients with multiple myeloma in the Chinese population.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female over the age of 18;&#xD;
  &#xD;
            2. First-degree relatives (including parents, children, and biological siblings) have&#xD;
               multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma&#xD;
               Diagnostic Criteria;&#xD;
  &#xD;
            3. Understand the purpose and procedure of this trial and voluntarily participate in this&#xD;
               screening study;&#xD;
  &#xD;
            4. Participants should be willing and able to follow the study follow-up plan and other&#xD;
               protocol requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma&#xD;
          (SMM), or multiple myeloma&#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>Peng Liu, PhD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peng Liu, PhD, MD</last_name>
      <phone>+8621-64041990</phone>
      <phone_ext>2925</phone_ext>
      <email>liu.peng@zs-hospital.sh.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jing Li, MD</last_name>
      <phone>+8621-64041990</phone>
      <phone_ext>2025</phone_ext>
      <email>li.jing6@zs-hospital.sh.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan Hospital，Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peng Liu, Ph.D</last_name>
        <phone>+862164041990</phone>
        <phone_ext>2925</phone_ext>
        <email>liu.peng@zs-hospital.sh.cn</email>
      </contact>
      <contact_backup>
        <last_name>Jing Li, M.D.</last_name>
        <phone>+862164041990</phone>
        <phone_ext>2025</phone_ext>
        <email>li.jing6@zs-hospital.sh.cn</email>
      </contact_backup>
      <investigator>
        <last_name>Peng Liu, Ph.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jing Li, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Li J, Wang Y, Liu P. The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. J Cancer. 2019 Aug 27;10(20):4807-4813. doi: 10.7150/jca.32103. eCollection 2019.</citation>
      <PMID>31598151</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
      <investigator_full_name>Peng Liu</investigator_full_name>
      <investigator_title>Head of Department of Hematology</investigator_title>
    </responsible_party>
    <keyword>Monoclonal Gammopathy of Undetermined Significance</keyword>
    <keyword>Multiple Myeloma</keyword>
    <keyword>Early Tumor Screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
      <mesh_term>Paraproteinemias</mesh_term>
      <mesh_term>Monoclonal Gammopathy of Undetermined Significance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05965115
  org study id: CHAPERONE
  nct id: NCT05965115
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of
        Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of
        screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with
        multiple myeloma in China population, and establish a prospective cohort of individuals with
        monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple
        myeloma. We will study these patients as a means to identify risk factors for progression to
        symptomatic multiple myeloma.
  The CHAPERONE study aims to assess the clinical significance of screening for monoclonal
        gammopathy in first-degree relatives of patients with multiple myeloma in China.
  
        The main objectives it aims to answer are:
  
          -  Main research objectives: To study the prevalence of MGUS, the time of disease
             progression, and its influencing factors in first-degree relatives of multiple myeloma
             patients in China.
  
          -  Secondary study objective: To explore the clinical/genomic/epigenetic features,
             survival, and quality of life of MGUS patients in first-degree relatives of multiple
             myeloma patients in China.
  
        All participants will receive M-protein screening by serum electrophoresis. Individuals with
        detected M-protein will undergo further diagnostic tests, and patients with MGUS will be
        carefully assessed and followed up.
  observational model: Cohort
  time perspective: Prospective
  measure: The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives
  time frame: 2 Years
  description: The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening
  measure: Time to progression (TTP) from MGUS to overt multiple myeloma
  time frame: 10 Years
  description: The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date.
  measure: Overall survival of MGUS patients
  time frame: 10 Years
  description: The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive.
  measure: Quality of life (QoL) of MGUS patients
  time frame: 10 Years
  description: QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period.
  intervention type: Diagnostic Test
  intervention name: Sample of Blood
  description: All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Peng Liu, PhD, MD
  role: Principal Investigator
  affiliation: Fudan University
  last name: Peng Liu, PhD, MD
  phone: +8621-64041990
  phone ext: 2925
  email: liu.peng@zs-hospital.sh.cn
  last name: Jing Li, MD
  phone: +8621-64041990
  phone ext: 2025
  email: li.jing6@zs-hospital.sh.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: China
  citation: Li J, Wang Y, Liu P. The impact on early diagnosis and survival outcome of M-protein screening-driven diagnostic approach to multiple myeloma in China: a cohort study. J Cancer. 2019 Aug 27;10(20):4807-4813. doi: 10.7150/jca.32103. eCollection 2019.
  PMID: 31598151
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Zhongshan Hospital
  investigator full name: Peng Liu
  investigator title: Head of Department of Hematology
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Paraproteinemias
  mesh term: Monoclonal Gammopathy of Undetermined Significance
  sharing ipd: Undecided