<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/NCT03750890</url>
  </required_header>
  <id_info>
    <org_study_id>ZWZ2018</org_study_id>
    <nct_id>NCT03750890</nct_id>
  </id_info>
  <brief_title>Visual Study of Molecular Genotype in Glioma Evolution</brief_title>
  <official_title>A New Strategy for the Visulation of Molecular Genotype in Glioma Evolution Based on the Radiomics and Microomics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</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 key molecular changes in the progression of glioma are closely related to tumor&#xD;
      heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a&#xD;
      visually quantitative assessment criteria about the key molecular typing of glioma is still&#xD;
      absent. Based on the previous research, this project intends to establish a multi-dimensional&#xD;
      database of glioma from clinical, radiomics and microomics levels. The investigators aim to&#xD;
      filter out the specific molecular markers in the progression of glioma and explore the&#xD;
      intrinsic connection of radiomics features and microomics molecular markers by using&#xD;
      bioinformatics integration analysis and artificial intelligence multiple kernel learning.&#xD;
      Thus, the investigators could determine the specific molecular mechanism in the progression&#xD;
      of glioma, and establish a visually quantitative assessment system of pre-operative precisive&#xD;
      grading, molecular typing discrimination and prognosis prediction. The completion of this&#xD;
      project is of great significance for improving molecular diagnostic level of glioma, guiding&#xD;
      individualized diagnosis and treatment decisions, and improving the survival rate of&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>the radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）in the progression of glioma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)</measure>
    <time_frame>through study completion, an average of 3 years</time_frame>
    <description>the key molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features) in the progression of glioma</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Glioma of Brain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive patients who were suspected of having brain gliomas on the basis of clinical&#xD;
        findings and who were previously diagnosed with brain gliomas underwent MRI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. postoperative pathological and genetic test confirmed brain glioma;&#xD;
&#xD;
          2. The preoperative Clear and complete multimodal imaging data were collected within 10&#xD;
             days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who underwent surgery more than 4 weeks after MRI;&#xD;
&#xD;
          2. patients with motion artifacts.&#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_contact>
    <last_name>Wenzhen Zhu, doctor</last_name>
    <phone>8613886018612</phone>
    <email>zhuwenzhen8612@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhenxiong Wang</name>
      <address>
        <city>Wuhan</city>
        <state>Choose A State Or Province</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenxiong Wang</last_name>
      <email>453839056@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 24, 2019</last_update_submitted>
  <last_update_submitted_qc>March 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03750890
org study id: ZWZ2018
nct id: NCT03750890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The key molecular changes in the progression of glioma are closely related to tumor
      heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a
      visually quantitative assessment criteria about the key molecular typing of glioma is still
      absent. Based on the previous research, this project intends to establish a multi-dimensional
      database of glioma from clinical, radiomics and microomics levels. The investigators aim to
      filter out the specific molecular markers in the progression of glioma and explore the
      intrinsic connection of radiomics features and microomics molecular markers by using
      bioinformatics integration analysis and artificial intelligence multiple kernel learning.
      Thus, the investigators could determine the specific molecular mechanism in the progression
      of glioma, and establish a visually quantitative assessment system of pre-operative precisive
      grading, molecular typing discrimination and prognosis prediction. The completion of this
      project is of great significance for improving molecular diagnostic level of glioma, guiding
      individualized diagnosis and treatment decisions, and improving the survival rate of
      patients.
observational model: Case-Only
time perspective: Prospective
measure: radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）
time frame: through study completion, an average of 3 years
description: the radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）in the progression of glioma
measure: microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)
time frame: through study completion, an average of 3 years
description: the key molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features) in the progression of glioma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wenzhen Zhu, doctor
phone: 8613886018612
email: zhuwenzhen8612@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Glioma