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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

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

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

Exclusion Criteria:

  • Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
  • Lack of valid ethical committee approval.
04

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
05

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

06

Study locations

50 of 57 sites recruiting
  • University Hospital Aachen
    Aachen, 52074, Germany
    Recruiting
  • Klinikum Augsburg
    Augsburg, 86156, Germany
    Recruiting
  • Helios Klinikum Berlin-Buch
    Berlin, 13125, Germany
    Recruiting
  • Charite Campus, University of Berlin
    Berlin, 13353, Germany
    Recruiting
  • Evangelisches Krankenhaus Bielefeld
    Bielefeld, 33617, Germany
    Recruiting
  • Klinikum Braunschweig
    Braunschweig, 38118, Germany
    Recruiting
  • Klinikum Bremen-Mitte
    Bremen, 28177, Germany
    Recruiting
  • Klinikum Chemnitz
    Chemnitz, 09116, Germany
    Recruiting
  • University Hospital Cologne
    Cologne, 50924, Germany
    Not yet recruiting
  • Carl-Thiem-Klinikum Cottbus
    Cottbus, 03048, Germany
    Recruiting
  • Vestische Kinder- und Jugendklinik, University Witten/Herdecke
    Datteln, 45711, Germany
    Active, not recruiting
  • Klinikum Dortmund
    Dortmund, 44137, Germany
    Recruiting
  • University Hospital Dresden
    Dresden, 01307, Germany
    Recruiting
  • Klinikum Duisburg
    Duisburg, 47055, Germany
    Active, not recruiting
  • Universitäts-Kinderklinik Düsseldorf
    Düsseldorf, 40225, Germany
    Recruiting
  • HELIOS Klinikum-Erfurt
    Erfurt, 99089, Germany
    Recruiting
  • University Hospital Erlangen
    Erlangen, 91054, Germany
    Recruiting
  • University Hospital Essen
    Essen, 45147, Germany
    Recruiting
  • University Hospital Frankfurt/Main
    Frankfurt, 60590, Germany
    Recruiting
  • University Hospital Freiburg
    Freiburg im Breisgau, 79106, Germany
    Recruiting
  • Universitätsklinikum Gießen und Marburg
    Giessen, 35392, Germany
    Recruiting
  • Georg-August-Universität Göttingen
    Göttingen, 37075, Germany
    Recruiting
  • University Hospital Greifswald
    Greifswald, 17475, Germany
    Recruiting
  • University Hospital Halle/Saale
    Halle, 06120, Germany
    Recruiting
  • University Medical Center Hamburg-Eppendorf
    Hamburg, 20246, Germany
    Recruiting
  • Medizinische Hochschule Hannover
    Hanover, 30625, Germany
    Recruiting
  • Angelika-Lautenschläger-Klinik
    Heidelberg, 69120, Germany
    Recruiting
  • SLK-Kliniken
    Heilbronn, 74078, Germany
    Recruiting
  • Gemeinschaftskrankenhaus Herdecke
    Herdecke, 58313, Germany
    Recruiting
  • University Hospital Homburg/Saar
    Homburg, 66421, Germany
    Recruiting
  • University Hopsital Jena
    Jena, 07740, Germany
    Recruiting
  • Städtisches Klinikum Karlsruhe
    Karlsruhe, 76133, Germany
    Recruiting
  • Klinikum Kassel
    Kassel, 34125, Germany
    Active, not recruiting
  • UK-SH Campus Kiel
    Kiel, 24105, Germany
    Recruiting
  • Gemeinschaftsklinikum Koblenz-Mayen
    Koblenz, 56073, Germany
    Recruiting
  • HELIOS Klinikum Krefeld
    Krefeld, 47805, Germany
    Not yet recruiting
  • University Hospital Leipzig
    Leipzig, 04103, Germany
    Active, not recruiting
  • Universitätsklinikum Schleswig-Holstein
    Lübeck, 23538, Germany
    Recruiting
  • University Hospital Magdeburg
    Magdeburg, 39120, Germany
    Recruiting
  • University Hospital Mainz
    Mainz, 55131, Germany
    Recruiting
  • University Hospital Mannheim
    Mannheim, 68167, Germany
    Recruiting
  • Johannes Wesling Klinikum Minden
    Minden, 32429, Germany
    Recruiting
  • Universität München - von Haunersches
    München, 80337, Germany
    Recruiting
  • Klinikum Schwabing, Pediatric Hospital of Technical University
    München, 80804, Germany
    Recruiting
  • Universitätsklinikum Münster
    Münster, 48149, Germany
    Recruiting
  • Cnopf'sche Kinderklinik
    Nuremberg, 90419, Germany
    Recruiting
  • Klinikum Oldenburg
    Oldenburg, 26133, Germany
    Recruiting
  • University Hospital Regensburg
    Regensburg, 93053, Germany
    Recruiting
  • University Hospital Rostock
    Rostock, 18057, Germany
    Recruiting
  • Asklepios Klinik Sankt Augustin
    Sankt Augustin, 53757, Germany
    Recruiting
  • Helios Kliniken Schwerin
    Schwerin, 19049, Germany
    Recruiting
  • Klinikum Stuttgart
    Stuttgart, 70176, Germany
    Recruiting
  • Universitätsklinik Tübingen
    Tübingen, 72076, Germany
    Recruiting
  • University Hospital Ulm
    Ulm, 89075, Germany
    Recruiting
  • Dr. Horst Schmidt Kliniken
    Wiesbaden, 65199, Germany
    Withdrawn
  • Klinikum der Stadt Wolfsburg
    Wolfsburg, 38440, Germany
    Recruiting
  • Universotätsklinikum Würzburg
    Würzburg, 97080, Germany
    Recruiting
07

Registry details

Key details

Study ID
NCT02417324
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
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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