HIT-REZ-REGISTRY

Retrospective and prospective registration of all patients with refractory, progressive or relapsed disease of one of the above-mentioned tumour entities with the following objectives:

• Collection of clinical data to evaluate the incidence of refractory, progressive or relapsed diseases of the above-mentioned tumour entities
• Collection of clinical data on refractory, progressive or relapsed diseases of the above-mentioned tumour entities
• Collection of neuropathological and molecular biological data on refractory, progressive or relapsed diseases of the above-mentioned tumour entities
• Quality assurance in the diagnosis and treatment of therapy-refractory, progressive or relapsed diseases of the above-mentioned tumour entities
• Collection of tissue samples (tumour, cerebrospinal fluid, peripheral blood)

The registry is not a treatment study or a clinical trial of new drugs or treatment methods subject to the German Drug Act, Medical Devices Act, Radiation Protection Ordinance or X-ray Ordinance.

Parallel to the registry study, therapy recommendations can be obtained from the HIT-REZ study centre based on the current results of national (HIT-REZ-97 study and HIT-REZ-2005 study) and international relapse studies. The decision in favour of a therapy and the responsibility for its administration lies solely with the treating institution. The HITREZ study centre and the HIT reference institutions are still available to provide advice.

• Reference histologically confirmed medulloblastoma, pineoblastoma or other tumours of the pineal region (excluding pineocytoma and germ cell tumours), CNS PNETs (CNS neuroblastoma, CNS ganglioneuroblastoma, medulloepithelioma, ependymoblastoma) or ependymoma (WHO grade II and III) regardless of the location of the primary tumour (supratentorial, infratentorial, spinal).
• The reference neuropathological assessment is mandatory for the tumour material obtained during tumour surgery at initial diagnosis and should be repeated in the case of recurrent tumour surgery. In the case of peripheral tumour manifestations outside the CNS, a reference neuropathological assessment is also mandatory.
• Reference radiological (MRI cranial and holospinal) confirmation of refractory or progressive disease during primary therapy or first or further relapse during or after multimodal primary therapy and/or reference neuropathological/liquor cytological confirmation of relapse in a tissue sample/cerebrospinal fluid.
• Diagnosis of recurrence or refractory or progressive disease ≥ 01.02.2013
• Age ≥ 3 months, without upper age limit
• Written informed consent of the patient and/or the parents/legal representatives to participate in the registry, including the
• data collection, storage, processing and transfer.
• The preservation and transfer of tissue samples requires a separate declaration of consent.
• A positive ethics vote in favour of participation in the HIT-REZ registry by the responsible ethics committee for the treating institution.

E-Mail-contact to the Reference facilities:

Referenzzentrum für Neuropathologie:
referenzzentrum@uni-bonn.de

Referenzzentrum für Neuroradiologie:
hit@neuroradiologie.uni-wuerzburg.de

Referenzzentren für Radioonkologie:
Leipzig: rolf-dieter.kortmann@medizin.uni-leipzig.de, klaus.mueller@medizin.uni-leipzig.de, sabine.klagges@medizin.uni-leipzig.de
Essen:beate.timmermann@uk-essen.de

Referenzzentrum für Neurochirurgie:
krauss.j@nch.uni-wuerzburg.de

Referenzzentrum für Pediatric Targeted Therapy:
o.witt@dkfz.de; t.milde@dkfz.de