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RecruitingNCT02417324Updated Dec 4, 2025

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

An observational study in Childhood Brain Tumor, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 57 sites in Germany. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Childhood Brain Tumor

Keywords

  • medulloblastoma
  • ependymoma
  • pineal tumour
  • CPT
03

In context

Medulloblastoma

317 studies on the registry are indexed under Medulloblastoma; 51 are open to participants now.

This study's planned enrollment of 500 is above the median of 163 across 34 observational studies indexed under Medulloblastoma.

Browse Medulloblastoma studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
  • Lack of valid ethical committee approval.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

50 of 57 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02417324
Responsible party
Sponsor
First posted
Apr 15, 2015
Start date
Jan 2015
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Dec 4, 2025

Study contacts

Stefan Rutkowski, Prof.
Contact
hitchem@uke.de
+49-40-7410 ext. 58200
Martin Mynarek, MD
Contact
m.mynarek@uke.de
+49-40-7410 ext. 58200
Stefan Rutkowski, Prof.
principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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