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

Suspended

• 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.)

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

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.

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

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Helios Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Charite Campus, University of Berlin; 🇩🇪 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

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