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/NCT06026488</url>
    </required_header>
    <id_info>
      <org_study_id>DLBCL-RWS-01</org_study_id>
      <nct_id>NCT06026488</nct_id>
    </id_info>
    <brief_title>Real-World Study of DLBCL With Different Genetic Subtypes</brief_title>
    <official_title>A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruijin Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To collect and evaluate the data of real-world treatment regimen, efficacy, safety and&#xD;
        survival information of DLBCL patients with different genetic suptypes&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and&#xD;
        explore the clinical information on DLBCL patients with different genetic subtypes and to&#xD;
        analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL.&#xD;
        This study is a non-interventional real world, observational study and all registered data&#xD;
        are collected from real clinical practice cases. The medical data includes patient&#xD;
        demographic, tumor characteristics, laboratory examination, history of treatments, adverse&#xD;
        reactions, efficacy results and possible prognostic factors. The results can guide future&#xD;
        precision therapy for DLBCL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>3 Years</target_duration>
    <primary_outcome>
      <measure>PFS</measure>
      <time_frame>Baseline up to data cut-off (Up to approximately 9 years)</time_frame>
      <description>Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ORR</measure>
      <time_frame>End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]</time_frame>
      <description>Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CRR</measure>
      <time_frame>End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]</time_frame>
      <description>Complete Remission Rate (CRR) is defined as the proportion of patients with CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>Baseline up to data cut-off (Up to approximately 9 years)</time_frame>
      <description>Overall survival (OS) refers to the time from receiving the first dose to death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR</measure>
      <time_frame>Baseline up to data cut-off (Up to approximately 9 years)</time_frame>
      <description>Duration Of Remission (DOR) refers to the time from the first CR or PR to the time of the first PD or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTR</measure>
      <time_frame>Approximately up to 1 year</time_frame>
      <description>Time to remission (TTR) refers to the time from recruitment to the time first CR or PR</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>DLBCL - Diffuse Large B Cell Lymphoma</condition>
    <condition>Lymphoma</condition>
    <arm_group>
      <arm_group_label>All enrolled patients</arm_group_label>
      <description>All patient who signed the consent form for participation to the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Other</intervention_name>
      <description>real world treatment and survival of DLBCL patients in China</description>
      <arm_group_label>All enrolled patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD,&#xD;
          BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)&#xD;
  &#xD;
            -  Genetic subtype belonging to at least one of the seven subtypes by using next&#xD;
               generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others&#xD;
  &#xD;
            -  Fully comprehension and signature of the informed consent form (ICF) for participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who refuse to use reliable methods of contraception during pregnancy, lactation&#xD;
               or age-appropriate period&#xD;
  &#xD;
            -  Severe mental illness&#xD;
  &#xD;
            -  Patients deemed unsuitable for inclusion by the investigator&#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>Weili Zhao</last_name>
      <phone>+862164370045</phone>
      <phone_ext>610707</phone_ext>
      <email>zwl_trial@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pengpeng Xu</last_name>
      <phone>+862164370045</phone>
      <phone_ext>610707</phone_ext>
      <email>pengpeng_xu@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Weili Zhao, MD, PhD</last_name>
        <email>zhao.weili@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Pengpeng Xu, MD, PhD</last_name>
        <email>pengpeng_xu@126.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
      <investigator_full_name>Zhao Weili</investigator_full_name>
      <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>lymphoma</keyword>
    <keyword>DLBCL</keyword>
    <keyword>Genetic Subtype</keyword>
    <keyword>real world analysis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</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/NCT06026488
  org study id: DLBCL-RWS-01
  nct id: NCT06026488
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To collect and evaluate the data of real-world treatment regimen, efficacy, safety and
        survival information of DLBCL patients with different genetic suptypes
  DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and
        explore the clinical information on DLBCL patients with different genetic subtypes and to
        analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL.
        This study is a non-interventional real world, observational study and all registered data
        are collected from real clinical practice cases. The medical data includes patient
        demographic, tumor characteristics, laboratory examination, history of treatments, adverse
        reactions, efficacy results and possible prognostic factors. The results can guide future
        precision therapy for DLBCL.
  observational model: Cohort
  time perspective: Other
  measure: PFS
  time frame: Baseline up to data cut-off (Up to approximately 9 years)
  description: Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.
  measure: ORR
  time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
  description: Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)
  measure: CRR
  time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
  description: Complete Remission Rate (CRR) is defined as the proportion of patients with CR
  measure: OS
  time frame: Baseline up to data cut-off (Up to approximately 9 years)
  description: Overall survival (OS) refers to the time from receiving the first dose to death from any cause
  measure: DOR
  time frame: Baseline up to data cut-off (Up to approximately 9 years)
  description: Duration Of Remission (DOR) refers to the time from the first CR or PR to the time of the first PD or death from any cause
  measure: TTR
  time frame: Approximately up to 1 year
  description: Time to remission (TTR) refers to the time from recruitment to the time first CR or PR
  arm group label: All enrolled patients
  description: All patient who signed the consent form for participation to the study
  intervention type: Other
  intervention name: Other
  description: real world treatment and survival of DLBCL patients in China
  arm group label: All enrolled patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Weili Zhao
  phone: +862164370045
  phone ext: 610707
  email: zwl_trial@163.com
  last name: Pengpeng Xu
  phone: +862164370045
  phone ext: 610707
  email: pengpeng_xu@126.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Ruijin Hospital
  investigator full name: Zhao Weili
  investigator title: Principal Investigator, Clinical Professor
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse