Trial document





This trial has been registered retrospectively.
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  DRKS00007936

Trial Description

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Title

HIT-REZ-REGISTER - a multinational multicentre register for children, adolescents, and young adults with refractory, progressive or relapsed medulloblastomas, pineoblastomas, primitive neuroectodermal tumors of the CNS (CNS-PNETs) and ependymomas

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Trial Acronym

HIT-REZ-Register

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The HIT-REZ-Register is a register protocol which contains guidelines for the experienced oncologist in oder to perform a standardized diagnostics in relapsed brain tumors (medulloblastomas, pineoblastomas, CNS-PNETs and ependymomas). The goal of the register is a population based, standardized data collection and a standardized asservation of biological material. Addiontionally
the reigister should serve for quality assurance in the diagnostics using a central neuroradiological and neuropathological reference assessment.

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Brief Summary in Scientific Language

This protocol describes a multinational multicentre registry in the European German speaking area for children, adolescents and young adults with refractory, progressive or relpased medulloblastomas, pineoblastomas, primitive neuroectodermal tumors of the CNS (CNS-PNETs) and ependymomas. These tumor entities are rare diseases. In this situation patients will be often treated outside from clinical trials due to their different pretreatment and their different clinical and neurological preconditions. Aims of the registry are the retrospective and prospective registration of all patients with a refractory, progressive or relapsed diease of the above mentioned tumor entities. It serve for collection and analysis of clinical, neuropathological and molecular biological data of these patients. Additionnally it serve for quality assurance in the diagnostics and in the treatment of these patients and for the asservation of tissue samples (tumor, CSF samples, peripheral blood). The collected data and the tissue sampling are neccessary preconditions for future clinical trials and research projects.

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Organizational Data

  •   DRKS00007936
  •   2015/07/14
  •   [---]*
  •   yes
  •   Approved
  •   14-6034-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C71.6 -  Malignant neoplasm: Cerebellum
  •   C71.5 -  Malignant neoplasm: Cerebral ventricle
  •   C72.0 -  Malignant neoplasm: Spinal cord
  •   C75.3 -  Malignant neoplasm: Pineal gland
  •   C71.1 -  Malignant neoplasm: Frontal lobe
  •   C71.2 -  Malignant neoplasm: Temporal lobe
  •   C71.3 -  Malignant neoplasm: Parietal lobe
  •   C71.4 -  Malignant neoplasm: Occipital lobe
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Interventions/Observational Groups

  •   Observation arm: retrospective and prospective registration of all children, adolescents, and young adults with refractory, progressive or relapsed medulloblastomas, pineoblastomas, primitive neuroectodermal tumors of the CNS (CNS-PNETs) and ependymomas. It serve for collection and analysis of clinical, neuropathological and molecular biological data of these patients. Additionnally it serve for quality assurance in the diagnostics and in the treatment of these patients and for the asservation of tissue samples (tumor, CSF samples, peripheral blood). The collected data and the tissue sampling are neccessary preconditions for future clinical trials and research projects.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Retrospective and prospective registration of all patients with refractory, progressive and relapsed disease of the above mentioned tumor entities wth following aims:
1. Collection and analysis of clinical data in order to evaluate the incidence of relapses
2. Collection and analysis of clinical data of relapses
3. Collection and analysis of neuropathological and molecular biological data of relapses

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Secondary Outcome

Quality assurance of the diagnostics and of the treatment of refractory, progressive or relapsed diseases of the above mentioned tumor entities,
Collection and asservation of tissue samples (Tumor, CSF samples, peripheral blood)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/06
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Months
  •   no maximum age
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Additional Inclusion Criteria

Medulloblastoma, pineoblastoma or other tumors of the pineal region (pineocytoma and germ cell tumors are exluded), CNS-PNETs (CNS neuroblastoma, CNS ganglioneuroblastoma,
medulloepithelioma, ependymoblastoma) or ependymoma (WHO-Grade II or III) independently of the localization of the primary tumor (supratentorial, infratentorial, spinal); reference neuropathologically proven histology at new diagnosis and at relapse in case of re-operation; reference radiologically (MRI cranial and holospinal) proven refractory or progressive disease during first-line treatment or at the first or a multiple relapse and/or histologically/cytologically proven relapse within a tissue sample or a CSF sample; relapse/progress diagnosis after 01/02/2013; Age ≥ 3 months, no upper age limit; written informed consent by the patient/the parents/the guardians for data collection and analysis

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Exclusion Criteria

Enrollment into the HIT-REZ-97-Study or HIT-REZ-2005-Study

Cave: The enrollment into a prospective clinical trial for relapses does not exclude the enrollment into the HIT-REZ-Registry. Refractory, progressive or relapsed diseases prior and after these prospective clinical trials can be analyzed within this registry.

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Deutsches Krebsforschungszentrum Heidelberg (DKFZ)
    • Mr.  Prof. Dr. med.  Stefan  Pfister 
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Pädiatrische Hämatologie und Onkologie
    • Ms.  Prof. Dr. med.  Gudrun  Fleischhack 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Pädiatrische Hämatologie und Onkologie
    • Ms.  Ruth  Mikasch 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • DeutscheKinderkrebsstiftung
    • Ms.  Renate  Heymans 
    • Adenauerallee 134
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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