<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/NCT02238899</url>
  </required_header>
  <id_info>
    <org_study_id>HIT 2000 Interim Register</org_study_id>
    <nct_id>NCT02238899</nct_id>
  </id_info>
  <brief_title>Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma</brief_title>
  <official_title>Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, Central Nervous System (CNS)- Primitive Neuroectodermal Tumour (PNET), or Ependymoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All&#xD;
      german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in&#xD;
      the register. Object of the register is to maintain the quality of diagnostic standard by&#xD;
      using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).&#xD;
&#xD;
      Furthermore, the register should enable to continue the collection of epidemiologic data and&#xD;
      biological material (tumor material, CSF, and blood) for associated studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All&#xD;
      german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in&#xD;
      the register. Object of the register is to maintain the quality of diagnostic standard by&#xD;
      using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).&#xD;
&#xD;
      Furthermore, the register should enable to continue the collection of epidemiologic data and&#xD;
      biological material (tumor material, CSF, and blood) for associated studies.&#xD;
&#xD;
      The register gives recommendations for the therapy of the patients, but these are not&#xD;
      mandatory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Event free survival (EFS)</measure>
    <time_frame>up to 10 years</time_frame>
    <description>event free survival probability rates will be calculated</description>
  </primary_outcome>
  <enrollment type="Actual">354</enrollment>
  <condition>Medulloblastoma, Childhood</condition>
  <condition>Cerebral Primitive Neuroectodermal Tumor</condition>
  <condition>Ependymoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor material, CSF, and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma,&#xD;
        CNS-neuroblastoma), or ependymoma (WHO II/ III) and age at diagnosis 0-21 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age at diagnosis 0-21 years&#xD;
&#xD;
          -  histologically proven medulloblastoma, CNS-PNET (incl. pineoblastoma,&#xD;
             ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Rutkowski, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Hamburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>January 18, 2013</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</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>Ependymoma</mesh_term>
    <mesh_term>Medulloblastoma</mesh_term>
    <mesh_term>Neuroectodermal Tumors</mesh_term>
    <mesh_term>Neuroectodermal Tumors, Primitive</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/NCT02238899
org study id: HIT 2000 Interim Register
nct id: NCT02238899
lead sponsor: 
has dmc: No
The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All
      german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in
      the register. Object of the register is to maintain the quality of diagnostic standard by
      using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

      Furthermore, the register should enable to continue the collection of epidemiologic data and
      biological material (tumor material, CSF, and blood) for associated studies.
The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All
      german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in
      the register. Object of the register is to maintain the quality of diagnostic standard by
      using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

      Furthermore, the register should enable to continue the collection of epidemiologic data and
      biological material (tumor material, CSF, and blood) for associated studies.

      The register gives recommendations for the therapy of the patients, but these are not
      mandatory.
time perspective: Cross-Sectional
measure: Event free survival (EFS)
time frame: up to 10 years
description: event free survival probability rates will be calculated
Tumor material, CSF, and blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Stefan Rutkowski, Prof.
role: Principal Investigator
affiliation: University Hospital Hamburg
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Ependymoma
mesh term: Medulloblastoma
mesh term: Neuroectodermal Tumors
mesh term: Neuroectodermal Tumors, Primitive