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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineal tumours, or choroid plexus tumours 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).

Lack of valid ethical committee approval.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Event free survival

Due to the explorative character of the registry, outcome measures are not strictly defined. We added the most common outcome measures.

Time frame
10 years

Secondary outcomes

1

Pattern of relapse

Time frame
10 years
2

Overall survival

Time frame
10 years

Other outcomes

Sponsors and contacts

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