International HIT-MED Registry (I-HIT-MED)

Childhood Brain Tumor Clinical Trial

Official title:

International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02417324
• Other study ID #: I-HIT-MED Registry
• Status: Suspended
• Start date: January 2015
• Est. completion date: December 2029

Study information

• Verified date: July 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Brain Tumor
• Medulloblastoma

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen
Germany	Klinikum Augsburg	Augsburg
Germany	Charite Campus, University of Berlin	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Evangelisches Krankenhaus Bielefeld	Bielefeld
Germany	Klinikum Braunschweig	Braunschweig
Germany	Klinikum Bremen-Mitte	Bremen
Germany	Klinikum Chemnitz	Chemnitz
Germany	University Hospital Cologne	Cologne
Germany	Carl-Thiem-Klinikum Cottbus	Cottbus
Germany	Vestische Kinder- und Jugendklinik, University Witten/Herdecke	Datteln
Germany	Klinikum Dortmund	Dortmund
Germany	University Hospital Dresden	Dresden
Germany	Klinikum Duisburg	Duisburg
Germany	Universitäts-Kinderklinik Düsseldorf	Düsseldorf
Germany	HELIOS Klinikum-Erfurt	Erfurt
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Essen	Essen
Germany	University Hospital Frankfurt/Main	Frankfurt
Germany	University Hospital Freiburg	Freiburg
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Georg-August-Universität Göttingen	Göttingen
Germany	University Hospital Greifswald	Greifswald
Germany	University Hospital Halle/Saale	Halle
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Angelika-Lautenschläger-Klinik	Heidelberg
Germany	SLK-Kliniken	Heilbronn
Germany	Gemeinschaftskrankenhaus Herdecke	Herdecke
Germany	University Hospital Homburg/Saar	Homburg
Germany	University Hopsital Jena	Jena
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe
Germany	Klinikum Kassel	Kassel
Germany	UK-SH Campus Kiel	Kiel
Germany	Gemeinschaftsklinikum Koblenz-Mayen	Koblenz
Germany	HELIOS Klinikum Krefeld	Krefeld
Germany	University Hospital Leipzig	Leipzig
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	University Hospital Magdeburg	Magdeburg
Germany	University Hospital Mainz	Mainz
Germany	University Hospital Mannheim	Mannheim
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Klinikum Schwabing, Pediatric Hospital of Technical University	München
Germany	Universität München - von Haunersches	München
Germany	Universitätsklinikum Münster	Münster
Germany	Cnopf'sche Kinderklinik	Nürnberg
Germany	Klinikum Oldenburg	Oldenburg
Germany	University Hospital Regensburg	Regensburg
Germany	University Hospital Rostock	Rostock
Germany	Asklepios Klinik Sankt Augustin	Sankt Augustin
Germany	Helios Kliniken Schwerin	Schwerin
Germany	Klinikum Stuttgart	Stuttgart
Germany	Universitätsklinik Tübingen	Tübingen
Germany	University Hospital Ulm	Ulm
Germany	Klinikum der Stadt Wolfsburg	Wolfsburg
Germany	Universotätsklinikum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival	Due to the explorative character of the registry, outcome measures are not strictly defined. We added the most common outcome measures.	10 years
Secondary	Pattern of relapse		10 years
Secondary	Overall survival		10 years