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NCT Number: NCT02417324

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

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.

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Key information

Conditions

Childhood Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Ependymoma Glioma Medulloblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Pinealoma

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aachen, Aachen, Germany

Loading trial locations.

About this study

The following patients can be included in this registry:

Children and adults with

  • Medulloblastoma (MB)
  • Ependymoma
  • Pineal Tumours
  • Chroroid plexus tumours

Objectives of this registry:

To prospectively evaluate the clinical courses of patients with the eligible brain tumours, considering neuroradiological, pathological, and molecular / biological characteristics of the tumour and individual standard treatment data.

To collect biological specimens (tumour, CSF, peripheral blood) or their data to perform biological studies on

  • disease aetiology
  • molecular / biological risk factors influencing treatment response and survival
  • potential targets for drug treatment in future patients

To assess the use of systems for quality assurance during diagnosis and treatment of brain tumours.

To assess long-term follow-up, quality of survival, neuropsychology, and other patient-centred research in these very rare tumour subtypes in the context of the registry or in cooperation with external collaborators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Event free survival

    Time frame: 10 years

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

Secondary outcomes

  1. Pattern of relapse

    Time frame: 10 years

  2. Overall survival

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Mynarek, MD

CONTACT

[email protected]

+49-40-7410 ext. 58200

Stefan Rutkowski, Prof.

CONTACT

[email protected]

+49-40-7410 ext. 58200

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2029
Study completion
2029
First posted
Apr 15, 2015
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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