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Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT02238899
Collaborator
(none)
354
Enrollment
1
Location
47
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    354 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, Central Nervous System (CNS)- Primitive Neuroectodermal Tumour (PNET), or Ependymoma
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Event free survival (EFS) [up to 10 years]

      event free survival probability rates will be calculated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age at diagnosis 0-21 years

    • histologically proven medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III)

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Hamburg Germany 20246

    Sponsors and Collaborators

    • Universitätsklinikum Hamburg-Eppendorf

    Investigators

    • Principal Investigator: Stefan Rutkowski, Prof., University Hospital Hamburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitätsklinikum Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT02238899
    Other Study ID Numbers:
    • HIT 2000 Interim Register
    First Posted:
    Sep 12, 2014
    Last Update Posted:
    May 29, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Ependymoma
    Medulloblastoma
    Neuroectodermal Tumors
    Neuroectodermal Tumors, Primitive

    Study Results

    No Results Posted as of May 29, 2015