<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/NCT03005132</url>
  </required_header>
  <id_info>
    <org_study_id>2016-521-Rainy</org_study_id>
    <nct_id>NCT03005132</nct_id>
  </id_info>
  <brief_title>Integrative Analysis of Human Glioblastoma Multiforme</brief_title>
  <official_title>Integrative Analysis of Human Glioblastoma Multiforme</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ganzhou City People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Integrative analysis of GBM&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced&#xD;
      transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP)&#xD;
      array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and&#xD;
      its synchronous matched metastasis, as well as analyzed genomics of GBM characterized&#xD;
      previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>5 years overall survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>5 years disease-free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 years overall survival</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 years disease-free survival</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>GBM</condition>
  <arm_group>
    <arm_group_label>Normal brain tissue</arm_group_label>
    <description>Normal brain tissue from GBM patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GBM tissues</arm_group_label>
    <description>GBM tissues from GBM patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metastasis tissues</arm_group_label>
    <description>Metastasis tissues from GBM patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal brain tissue</intervention_name>
    <description>The investigators will extract total protein, DNA and RNA from the samples.</description>
    <arm_group_label>GBM tissues</arm_group_label>
    <arm_group_label>Metastasis tissues</arm_group_label>
    <arm_group_label>Normal brain tissue</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with GBM&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 75 years with histologically proven GBM&#xD;
&#xD;
          -  No severe major organ dysfunction&#xD;
&#xD;
          -  World Health Organization (WHO) performance status of 0 or 1&#xD;
&#xD;
          -  No prior cancer chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 76&#xD;
&#xD;
          -  Severe major organ dysfunction&#xD;
&#xD;
          -  WHO performance status of &gt;1&#xD;
&#xD;
          -  Prior cancer chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Da Fu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 10th People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoming Zhong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ganzhou City People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Da Fu, PhD</last_name>
    <phone>00-86-21-66301604</phone>
    <email>fu800da900@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yushui Ma, BS</last_name>
    <phone>00-86-21-66301604</phone>
    <email>mayushui2015@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Da Fu, PhD</last_name>
      <phone>00-86-21-66301604</phone>
      <email>fu800da900@126.com</email>
    </contact>
    <investigator>
      <last_name>Yushui Ma, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.</citation>
    <PMID>25651787</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Da Fu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>GBM; Integrative Analysis; WES</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators are willing to share data.</ipd_description>
  </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/NCT03005132
org study id: 2016-521-Rainy
nct id: NCT03005132
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Integrative analysis of GBM
The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced
      transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP)
      array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and
      its synchronous matched metastasis, as well as analyzed genomics of GBM characterized
      previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
observational model: Case-Control
time perspective: Retrospective
measure: 5 years overall survival
time frame: 5 years
measure: 5 years disease-free survival
time frame: 5 years
measure: 10 years overall survival
time frame: 10 years
measure: 10 years disease-free survival
time frame: 10 years
arm group label: Normal brain tissue
description: Normal brain tissue from GBM patients
arm group label: GBM tissues
description: GBM tissues from GBM patients
arm group label: Metastasis tissues
description: Metastasis tissues from GBM patients
intervention type: Other
intervention name: Normal brain tissue
description: The investigators will extract total protein, DNA and RNA from the samples.
arm group label: GBM tissues
arm group label: Metastasis tissues
arm group label: Normal brain tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Da Fu, PhD
role: Principal Investigator
affiliation: Shanghai 10th People's Hospital
last name: Xiaoming Zhong, MD
role: Study Director
affiliation: Ganzhou City People's Hospital
last name: Da Fu, PhD
phone: 00-86-21-66301604
email: fu800da900@126.com
last name: Yushui Ma, BS
phone: 00-86-21-66301604
email: mayushui2015@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PMID: 25651787
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Da Fu
investigator title: Principal Investigator
mesh term: Glioblastoma
sharing ipd: Yes
ipd description: The investigators are willing to share data.