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

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ClinicalTrials.gov Identifier: NCT02238899
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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
Medulloblastoma, Childhood Cerebral Primitive Neuroectodermal Tumor Ependymoma

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.


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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 : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014





Primary Outcome Measures :
  1. Event free survival (EFS) [ Time Frame: up to 10 years ]
    event free survival probability rates will be calculated


Biospecimen Retention:   Samples With DNA
Tumor material, CSF, and blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III) and age at diagnosis 0-21 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238899


Locations
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Germany
University Hospital
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Rutkowski, Prof. University Hospital Hamburg

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02238899     History of Changes
Other Study ID Numbers: HIT 2000 Interim Register
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Ependymoma
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue