<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/NCT03288168</url>
  </required_header>
  <id_info>
    <org_study_id>XH-17-014</org_study_id>
    <secondary_id>CNOG-MB001</secondary_id>
    <nct_id>NCT03288168</nct_id>
  </id_info>
  <brief_title>Children's and Adolescents' Medulloblastoma Molecular Subgroups in China</brief_title>
  <acronym>CNOG-MB001</acronym>
  <official_title>Multi-center Retrospective Study on Clinical Features and Molecular Subgroups of Children and Adolescents With Medulloblastoma in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Neuro-Oncology Group (CNOG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before&#xD;
      since the new World Health Organization (WHO) diagnosis criteria has put molecular marker&#xD;
      onto an ever important position. Reports and studies revealed highly correlated connection&#xD;
      between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG)&#xD;
      has launched many new studies on molecular subgroups-based specific treatment trails. In&#xD;
      China, children and adolescents with brain tumor have been treated variously for a long time&#xD;
      in lack of standardized comprehensive treatments. Same poor situation in basic research and&#xD;
      clinical studies makes the Chinese children with brain tumor hardly catch up with&#xD;
      international level in molecular diagnosis and specific treatments. There are limited&#xD;
      studies, which were conducted by immunohistochemistry for identifying medulloblastoma&#xD;
      molecular subgroups, indicating the similar correlation of the subgroups and outcomes to&#xD;
      world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in&#xD;
      May 2017, it makes studies from multiple centers in children's brain tumors become practical.&#xD;
      And the availability of DNA methylation array, NanoString and other methods in&#xD;
      medulloblastoma subgroup identification assures the quality of the method for this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies discovered that medulloblastoma is a group of tumors with different pathogenesis&#xD;
      through different pathways, and majorly can be divided into four molecular subgroups.&#xD;
      Moreover, multicenter retrospective studies from US, Canada and European Countries revealed&#xD;
      that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor&#xD;
      for the patient outcomes. This finding made WHO classification of tumours of central nervous&#xD;
      system consider the markers in molecular pathway be an ever important indicator in the new&#xD;
      diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing&#xD;
      becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA&#xD;
      methylation arrays or other molecular methods makes subgroup identification more reliable. In&#xD;
      China, there are limited single institutional studies, which were all conducted by&#xD;
      immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of&#xD;
      medulloblastoma, especially in pediatric patients. This multicenter retrospective study&#xD;
      enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member&#xD;
      institutions across the country, with available paraffin embedded samples and reliable&#xD;
      follow-up information, to assess the correlation of molecular subgroups of medulloblastoma&#xD;
      and outcomes in Chinese population.&#xD;
&#xD;
      This multicenter study recruits eligible patients from CNOG member institutions. Data&#xD;
      validation and verification is double conducted by each center and investigators in central&#xD;
      data base. Case report form (CRF) was designed by principle investigator and will be modified&#xD;
      in the period of uploading first 5 cases by each participated center. The estimated&#xD;
      enrollment is 200 cases after sample size assessment. Descriptive statistical analysis,&#xD;
      Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological&#xD;
      analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square&#xD;
      test will be used to validate the test efficiency of immunohistochemistry and NanoString&#xD;
      methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first</time_frame>
    <description>The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival</measure>
    <time_frame>Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.</time_frame>
    <description>The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Medulloblastoma, Childhood</condition>
  <arm_group>
    <arm_group_label>0-18 y/o Patients with Medulloblastoma</arm_group_label>
    <description>Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Either paraffin embedded tissue block or frozen tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents from 0-18 y/o, diagnosed with Medulloblastoma in CNOG-MB001 study&#xD;
        participated institutions in mainland China, with available detailed clinical records, full&#xD;
        followup records and available tumor samples, fitting eligibility criteria, are enrolled in&#xD;
        this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have classical histology posterior fossa medulloblastoma as&#xD;
             determined by institutional neuro-pathological evaluation.&#xD;
&#xD;
          -  Participants must have tumor tissue samples (either paraffin embedded tissue block or&#xD;
             frozen tissue) for NanoString test for distinguishing the molecular subgroups of&#xD;
             medulloblastoma in Xinhua hospital affiliated to Shanghai Jiaotong University School&#xD;
             of Medicine (SHXH).&#xD;
&#xD;
          -  Participants must provide tumor tissue samples (either paraffin embedded tissue block&#xD;
             or frozen tissue) for immunohistochemistry assessment in verifying the molecular&#xD;
             subgroups of medulloblastoma, or conduct the same immunohistochemistry test according&#xD;
             to central analysis in SHXH, and send the slides to SHXH for center reviewing.&#xD;
&#xD;
          -  Diagnostic imaging (pre and post operation (OP) contrast MRI or CT, Post-OP imaging&#xD;
             conducted within 72 hours, no later than 14 days) must be forwarded to SHXH for&#xD;
             central review to confirm eligibility.&#xD;
&#xD;
          -  Sufficient pathologic material must be available for central analysis and review in&#xD;
             SHXH.&#xD;
&#xD;
          -  The patients must have no previous radiotherapy or chemotherapy other than&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Ability to understand and willingness to comply with follow-up visits.&#xD;
&#xD;
          -  Life expectancy more than 4 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must not have received any prior tumor-directed therapy other than surgical&#xD;
             intervention and corticosteroids.&#xD;
&#xD;
          -  Tumor tissue sample not available for biological studies (from the initial diagnosis&#xD;
             and/or relapse).&#xD;
&#xD;
          -  Clinically significant unrelated systemic illness (e.g., serious infection or&#xD;
             significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would&#xD;
             compromise the patient's ability to tolerate standard treatment or would likely&#xD;
             interfere with study results.&#xD;
&#xD;
          -  Patients obtained no radiation and/or chemo therapies are not excluded in this study&#xD;
             since the nature history of the disease will also be evaluated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie MA, MD, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuzhou General Hospital of Nanjing Military Region</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong 999 Brain Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510510</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaocheng People's Hospital</name>
      <address>
        <city>Liaocheng</city>
        <state>Shandong</state>
        <zip>252000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200086</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renji Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>April 16, 2020</last_update_submitted>
  <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jie Ma, MD, PhD</investigator_full_name>
    <investigator_title>Head of Department of Pediatric Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Observation</keyword>
  <keyword>Molecular Subgroup</keyword>
  <keyword>NanoString</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Medulloblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03288168
org study id: XH-17-014
secondary id: CNOG-MB001
nct id: NCT03288168
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before
      since the new World Health Organization (WHO) diagnosis criteria has put molecular marker
      onto an ever important position. Reports and studies revealed highly correlated connection
      between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG)
      has launched many new studies on molecular subgroups-based specific treatment trails. In
      China, children and adolescents with brain tumor have been treated variously for a long time
      in lack of standardized comprehensive treatments. Same poor situation in basic research and
      clinical studies makes the Chinese children with brain tumor hardly catch up with
      international level in molecular diagnosis and specific treatments. There are limited
      studies, which were conducted by immunohistochemistry for identifying medulloblastoma
      molecular subgroups, indicating the similar correlation of the subgroups and outcomes to
      world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in
      May 2017, it makes studies from multiple centers in children's brain tumors become practical.
      And the availability of DNA methylation array, NanoString and other methods in
      medulloblastoma subgroup identification assures the quality of the method for this study.
Studies discovered that medulloblastoma is a group of tumors with different pathogenesis
      through different pathways, and majorly can be divided into four molecular subgroups.
      Moreover, multicenter retrospective studies from US, Canada and European Countries revealed
      that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor
      for the patient outcomes. This finding made WHO classification of tumours of central nervous
      system consider the markers in molecular pathway be an ever important indicator in the new
      diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing
      becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA
      methylation arrays or other molecular methods makes subgroup identification more reliable. In
      China, there are limited single institutional studies, which were all conducted by
      immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of
      medulloblastoma, especially in pediatric patients. This multicenter retrospective study
      enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member
      institutions across the country, with available paraffin embedded samples and reliable
      follow-up information, to assess the correlation of molecular subgroups of medulloblastoma
      and outcomes in Chinese population.

      This multicenter study recruits eligible patients from CNOG member institutions. Data
      validation and verification is double conducted by each center and investigators in central
      data base. Case report form (CRF) was designed by principle investigator and will be modified
      in the period of uploading first 5 cases by each participated center. The estimated
      enrollment is 200 cases after sample size assessment. Descriptive statistical analysis,
      Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological
      analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square
      test will be used to validate the test efficiency of immunohistochemistry and NanoString
      methods.
observational model: Cohort
time perspective: Retrospective
measure: Overall Survival
time frame: Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first
description: The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
measure: Event Free Survival
time frame: Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.
description: The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
arm group label: 0-18 y/o Patients with Medulloblastoma
description: Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group.
Either paraffin embedded tissue block or frozen tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Jie MA, MD, Phd
role: Study Chair
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Jie Ma, MD, PhD
investigator title: Head of Department of Pediatric Neurosurgery
mesh term: Medulloblastoma
sharing ipd: Undecided