Clinical trial NCT02417324: International HIT-MED Registry (I-HIT-MED)
Official title: International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Childhood Brain Tumor
Keywords: medulloblastoma
ependymoma
pineoblastoma
CNS-PNET
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults with

* Medulloblastoma (MB)
* Ependymoma
* CNS-primitive neuroectodermal tumours (CNS-PNET) including CNS neuroblastoma, CNS ganglioneuroblastoma, Medulloepithelioma, Ependymoblastoma, CNS-PNET not otherwise specified (NOS)
* Pineoblastoma
* Pineal parenchymal tumour of intermediate differentiation
* Papillary tumour of the pineal region Who are not included in prospective clinical trials for these conditions

Brief summary: The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineoblastoma, or CNS-primitive neuroectodermal tumour (CNS-PNET) in Germany and other countries that fulfil national ethic requirements for participation in this registry. These tumours are rare diseases, and many patients are treated outside of clinical trials. The I-HIT-MED registry allows collection of data und biological material from those patients, and provides a basis for standard treatment recommendations and counselling. It aims to improve the international cooperation and the medical knowledge in these rare diseases. Within the I-HIT-MED registry, it is a goal to maintain and improve networks for quality assurance in national groups where they are already established, and to support the implementation in national groups, where there is no quality assurance network yet.

Detailed description: The following patients can be included in this registry:

Children and adults with

* Medulloblastoma (MB)
* Ependymoma
* CNS-primitive neuroectodermal tumours (CNS-PNET) including CNS neuroblastoma, CNS ganglioneuroblastoma, Medulloepithelioma, Ependymoblastoma, CNS-PNET not otherwise specified (NOS)
* Pineoblastoma
* Pineal parenchymal tumour of intermediate differentiation
* Papillary tumour of the pineal region Who are not included in prospective clinical trials for these conditions

The objectives of this registry are

* To evaluate clinical data on the epidemiology of the above mentioned CNS-neoplasms, and the use and outcome of different treatment regimens, for patients who cannot be included in prospective trials.
* To provide guidelines to establish, maintain and improve systems for quality assurance in the diagnostic assessments and treatment of brain tumours.

To collect biological specimens (tumour, cerebrospinal fluid (CSF), peripheral blood) and perform comprehensive biological studies with the aim to improve our understanding of these diseases and their aetiology, to improve therapy stratification and to improve or develop new treatment options.

- To collect clinical data for cooperative scientific projects (e.g. new follow-up studies, studies on quality of survival, neuropsychology etc.)

Eligibility criteria: Inclusion Criteria:

* all patients with above mentioned diagnosis of all ages (except for ependymoma WHO I°, pineal parenchymal tumour of intermediate differentiation and papillary tumour of the pineal region, who will be registered only if primary diagnosis was before the 18th birthday)
* any localisation of the primary tumour
* all clinical stages
* First diagnosis after 01.01.2012
* No inclusion into a prospective clinical trial for the same diagnosis, due to non-eligibility, national lack of trial approval, or individual refusal of participation.
* Written informed consent for data transfer and tumour sample submission according to the laws of each participating country is necessary.
* National and/ or local ethical committee approval according to the laws of each participating country is necessary.

Exclusion Criteria:

* Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
* Lack of valid ethical committee approval.

Primary outcomes:
measure: Event free survival
timeFrame: 10 years
Secondary outcomes:
measure: Pattern of relapse
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Charite Campus, University of Berlin
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik, University Witten/Herdecke
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Duisburg
country: Germany
facility: Klinikum Duisburg
city: Düsseldorf
country: Germany
facility: Universitäts-Kinderklinik Düsseldorf
city: Erfurt
country: Germany
facility: HELIOS Klinikum-Erfurt
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt/Main
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen
city: Halle
country: Germany
facility: University Hospital Halle/Saale
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Angelika-Lautenschläger-Klinik
city: Heilbronn
country: Germany
facility: SLK-Kliniken
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus Herdecke
city: Homburg
country: Germany
facility: University Hospital Homburg/Saar
city: Jena
country: Germany
facility: University Hopsital Jena
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Kiel
country: Germany
facility: UK-SH Campus Kiel
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Koblenz-Mayen
city: Krefeld
country: Germany
facility: HELIOS Klinikum Krefeld
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
city: Mainz
country: Germany
facility: University Hospital Mainz
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Universität München - von Haunersches
city: München
country: Germany
facility: Klinikum Schwabing, Pediatric Hospital of Technical University
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Würzburg
country: Germany
facility: Universotätsklinikum Würzburg
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Stefan Rutkowski, Prof.
role: PRINCIPAL_INVESTIGATOR
References: