<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/NCT04478877</url>
  </required_header>
  <id_info>
    <org_study_id>GWMO01</org_study_id>
    <nct_id>NCT04478877</nct_id>
  </id_info>
  <brief_title>Establishment and Characterization of Meningioma Patient-derived Organoids</brief_title>
  <official_title>Establishment and Characterization of Meningioma Patient-derived Organoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      In this study, meningioma organoids will be established from patients' tissues and the&#xD;
      characterization of the organoid will be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims and Hypothesis to be tested:&#xD;
&#xD;
      The investigators hypothesized that the derived organoid should have a similar morphological&#xD;
      and genetic mutation signatures to the patient primary tissue.&#xD;
&#xD;
      Study period: 1 year for patient recruitment and organoid generation from patient tumor&#xD;
&#xD;
      Study population: 30&#xD;
&#xD;
      Study samples:&#xD;
&#xD;
      Patient's meningioma tumor sample are collected from patients with surgical needs. Sample&#xD;
      collected are used for organoid culture. Morphological and genetic characteristics will be&#xD;
      compared between the patient tumor sample and the corresponding derived organoids&#xD;
&#xD;
      Primary outcome measures:&#xD;
&#xD;
      Whole exome sequencing data of patient tumor tissue and patients-derived organoids&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Actual">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Whole exome sequencing data</measure>
    <time_frame>7 days</time_frame>
    <description>DNA extracted from patient tumor tissue and patients-derived organoids will be perform whole exome sequencing for genetic characterization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunostaining</measure>
    <time_frame>7 days</time_frame>
    <description>H&amp;E staining and meningioma markers immunostaining</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Meningioma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Meningioma tumor sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with meningioma admitted to Prince Wales Hospitals neurosurgical services&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (aged &gt;18 years) with meningioma&#xD;
&#xD;
          2. Admission into Prince Wales hospitals neurosurgical services&#xD;
&#xD;
          3. Patients with surgical needs of meningioma removal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients (or next-of-kin as appropriate) refuse to participate into the study&#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>George KC Wong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</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>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>George KC Wong</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningioma</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/NCT04478877
org study id: GWMO01
nct id: NCT04478877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, meningioma organoids will be established from patients' tissues and the
      characterization of the organoid will be performed.
Aims and Hypothesis to be tested:

      The investigators hypothesized that the derived organoid should have a similar morphological
      and genetic mutation signatures to the patient primary tissue.

      Study period: 1 year for patient recruitment and organoid generation from patient tumor

      Study population: 30

      Study samples:

      Patient's meningioma tumor sample are collected from patients with surgical needs. Sample
      collected are used for organoid culture. Morphological and genetic characteristics will be
      compared between the patient tumor sample and the corresponding derived organoids

      Primary outcome measures:

      Whole exome sequencing data of patient tumor tissue and patients-derived organoids
observational model: Other
time perspective: Prospective
measure: Whole exome sequencing data
time frame: 7 days
description: DNA extracted from patient tumor tissue and patients-derived organoids will be perform whole exome sequencing for genetic characterization.
measure: Immunostaining
time frame: 7 days
description: H&E staining and meningioma markers immunostaining
Meningioma tumor sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George KC Wong
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: George KC Wong
investigator title: Clinical Professor
mesh term: Meningioma