International HIT-MED Registry (I-HIT-MED)
- Conditions
- Childhood Brain Tumor
- Registration Number
- NCT02417324
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.)
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 500
- 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.
- Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
- Lack of valid ethical committee approval.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event free survival 10 years Due to the explorative character of the registry, outcome measures are not strictly defined. We added the most common outcome measures.
- Secondary Outcome Measures
Name Time Method Pattern of relapse 10 years Overall survival 10 years
Trial Locations
- Locations (56)
University Hospital Aachen
🇩🇪Aachen, Germany
Vestische Kinder- und Jugendklinik, University Witten/Herdecke
🇩🇪Datteln, Germany
University Hospital Dresden
🇩🇪Dresden, Germany
University Hospital Freiburg
🇩🇪Freiburg, Germany
Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany
University Hospital Halle/Saale
🇩🇪Halle, Germany
Gemeinschaftskrankenhaus Herdecke
🇩🇪Herdecke, Germany
UK-SH Campus Kiel
🇩🇪Kiel, Germany
University Hospital Leipzig
🇩🇪Leipzig, Germany
University Hospital Mannheim
🇩🇪Mannheim, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Klinikum Schwabing, Pediatric Hospital of Technical University
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Asklepios Klinik Sankt Augustin
🇩🇪Sankt Augustin, Germany
Universotätsklinikum Würzburg
🇩🇪Würzburg, Germany
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinikum Bremen-Mitte
🇩🇪Bremen, Germany
University Hospital Erlangen
🇩🇪Erlangen, Germany
University Hospital Homburg/Saar
🇩🇪Homburg, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Gemeinschaftsklinikum Koblenz-Mayen
🇩🇪Koblenz, Germany
HELIOS Klinikum Krefeld
🇩🇪Krefeld, Germany
University Hospital Mainz
🇩🇪Mainz, Germany
University Hospital Regensburg
🇩🇪Regensburg, Germany
Klinikum der Stadt Wolfsburg
🇩🇪Wolfsburg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Evangelisches Krankenhaus Bielefeld
🇩🇪Bielefeld, Germany
Klinikum Duisburg
🇩🇪Duisburg, Germany
HELIOS Klinikum-Erfurt
🇩🇪Erfurt, Germany
University Hospital Essen
🇩🇪Essen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Angelika-Lautenschläger-Klinik
🇩🇪Heidelberg, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Klinikum Chemnitz
🇩🇪Chemnitz, Germany
University Hospital Cologne
🇩🇪Cologne, Germany
Carl-Thiem-Klinikum Cottbus
🇩🇪Cottbus, Germany
Universitäts-Kinderklinik Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinikum Gießen und Marburg
🇩🇪Gießen, Germany
University Hospital Greifswald
🇩🇪Greifswald, Germany
University Hopsital Jena
🇩🇪Jena, Germany
Cnopf'sche Kinderklinik
🇩🇪Nürnberg, Germany
University Hospital Rostock
🇩🇪Rostock, Germany
Helios Kliniken Schwerin
🇩🇪Schwerin, Germany
Universitätsklinik Tübingen
🇩🇪Tübingen, Germany
University Hospital Ulm
🇩🇪Ulm, Germany
Charite Campus, University of Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Klinikum Dortmund
🇩🇪Dortmund, Germany
University Hospital Frankfurt/Main
🇩🇪Frankfurt, Germany
SLK-Kliniken
🇩🇪Heilbronn, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
University Hospital Magdeburg
🇩🇪Magdeburg, Germany
Universität München - von Haunersches
🇩🇪München, Germany