Childhood Brain TumorNCT02417324
International HIT-MED Registry (I-HIT-MED)
An observational study of Childhood Brain Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 57 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Brain Tumor
- How many people
- 500 participants
- Where
- 57 sitesGermany
- Study dates
- Jan 2015to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
- Lack of valid ethical committee approval.
Trial locations and contacts
57 sites in 1 country. Contact the study team or a site near you to ask about taking part.
57 sites in 1 country
Germany57 sites, 52 recruiting
- Recruiting
University Hospital Aachen
Aachen, 52074
- Recruiting
Klinikum Augsburg
Augsburg, 86156
- Recruiting
Helios Klinikum Berlin-Buch
Berlin, 13125
- Recruiting
Charite Campus, University of Berlin
Berlin, 13353
- Recruiting
Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617
- Recruiting
Klinikum Braunschweig
Braunschweig, 38118
- Recruiting
Klinikum Bremen-Mitte
Bremen, 28177
- Recruiting
Klinikum Chemnitz
Chemnitz, 09116
- Not yet recruiting
University Hospital Cologne
Cologne, 50924
- Recruiting
Carl-Thiem-Klinikum Cottbus
Cottbus, 03048
- Active, not recruiting
Vestische Kinder- und Jugendklinik, University Witten/Herdecke
Datteln, 45711
- Recruiting
Klinikum Dortmund
Dortmund, 44137
- Recruiting
University Hospital Dresden
Dresden, 01307
- Active, not recruiting
Klinikum Duisburg
Duisburg, 47055
- Recruiting
Universitäts-Kinderklinik Düsseldorf
Düsseldorf, 40225
- Recruiting
HELIOS Klinikum-Erfurt
Erfurt, 99089
- Recruiting
University Hospital Erlangen
Erlangen, 91054
- Recruiting
University Hospital Essen
Essen, 45147
- Recruiting
University Hospital Frankfurt/Main
Frankfurt, 60590
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau, 79106
- Recruiting
Universitätsklinikum Gießen und Marburg
Giessen, 35392
- Recruiting
Georg-August-Universität Göttingen
Göttingen, 37075
- Recruiting
University Hospital Greifswald
Greifswald, 17475
- Recruiting
University Hospital Halle/Saale
Halle, 06120
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Stefan Rutkowski, Prof., +49-40-7410 ext. 58200, hitchem@uke.de
Martin Mynarek, MD, +49-40-7410 ext. 58200, m.mynarek@uke.de
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
- Recruiting
Angelika-Lautenschläger-Klinik
Heidelberg, 69120
- Recruiting
SLK-Kliniken
Heilbronn, 74078
- Recruiting
Gemeinschaftskrankenhaus Herdecke
Herdecke, 58313
- Recruiting
University Hospital Homburg/Saar
Homburg, 66421
- Recruiting
University Hopsital Jena
Jena, 07740
- Recruiting
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
- Active, not recruiting
Klinikum Kassel
Kassel, 34125
- Recruiting
UK-SH Campus Kiel
Kiel, 24105
- Recruiting
Gemeinschaftsklinikum Koblenz-Mayen
Koblenz, 56073
- Not yet recruiting
HELIOS Klinikum Krefeld
Krefeld, 47805
- Active, not recruiting
University Hospital Leipzig
Leipzig, 04103
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
- Recruiting
University Hospital Magdeburg
Magdeburg, 39120
- Recruiting
University Hospital Mainz
Mainz, 55131
- Recruiting
University Hospital Mannheim
Mannheim, 68167
- Recruiting
Johannes Wesling Klinikum Minden
Minden, 32429
- Recruiting
Universität München - von Haunersches
München, 80337
- Recruiting
Klinikum Schwabing, Pediatric Hospital of Technical University
München, 80804
- Recruiting
Universitätsklinikum Münster
Münster, 48149
- Recruiting
Cnopf'sche Kinderklinik
Nuremberg, 90419
- Recruiting
Klinikum Oldenburg
Oldenburg, 26133
- Recruiting
University Hospital Regensburg
Regensburg, 93053
- Recruiting
University Hospital Rostock
Rostock, 18057
- Recruiting
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
- Recruiting
Helios Kliniken Schwerin
Schwerin, 19049
- Recruiting
Klinikum Stuttgart
Stuttgart, 70176
- Recruiting
Universitätsklinik Tübingen
Tübingen, 72076
- Recruiting
University Hospital Ulm
Ulm, 89075
- Withdrawn
Dr. Horst Schmidt Kliniken
Wiesbaden, 65199
- Recruiting
Klinikum der Stadt Wolfsburg
Wolfsburg, 38440
- Recruiting
Universotätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours
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.
- Conditions
- Childhood Brain Tumor
- Keywords
- medulloblastoma, ependymoma, pineal tumour, CPT
- Medical subject headings
- Medulloblastoma, Ependymoma, Pinealoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Due to the explorative character of the registry, outcome measures are not strictly defined. We added the most common outcome measures.
Measured: 10 years
Secondary outcomes (2)
Pattern of relapse
Measured: 10 years
Overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Brain TumorStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Rutkowski, Prof., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417324
- Sponsor's protocol ID
- I-HIT-MED Registry
- Status last verified
- Nov 2025
- First submitted
- 4 Feb 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours
- ClinicalTrials.gov ID
- NCT02417324
- Acronym / sponsor ID
- I-HIT-MED Registry
- Conditions
- Childhood Brain Tumor
- Keywords
- medulloblastoma, ependymoma, pineal tumour, CPT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Registration in another clinical trial for the same diagnosis (relapse is defined as a second diagnosis).
- Lack of valid ethical committee approval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Pattern of relapse
Time frame: 10 years
Overall survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Rutkowski, Prof. principal investigator
Universitätsklinikum Hamburg-Eppendorf
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Brain Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 57 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Rutkowski, Prof. (+49-40-7410 ext. 58200, hitchem@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.