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

November 27, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Stefan Rutkowski, Prof.
  • Phone Number: 58200 +49-40-7410
  • Email: hitchem@uke.de

Study Contact Backup

  • Name: Martin Mynarek, MD
  • Phone Number: 58200 +49-40-7410
  • Email: m.mynarek@uke.de

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • University Hospital Aachen
      • Augsburg, Germany, 86156
        • Recruiting
        • Klinikum Augsburg
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Campus, University of Berlin
      • Bielefeld, Germany, 33617
        • Recruiting
        • Evangelisches Krankenhaus Bielefeld
      • Braunschweig, Germany, 38118
        • Recruiting
        • Klinikum Braunschweig
      • Bremen, Germany, 28177
        • Recruiting
        • Klinikum Bremen-Mitte
      • Chemnitz, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz
      • Cologne, Germany, 50924
        • Not yet recruiting
        • University Hospital Cologne
      • Cottbus, Germany, 03048
        • Recruiting
        • Carl-Thiem-Klinikum Cottbus
      • Datteln, Germany, 45711
        • Active, not recruiting
        • Vestische Kinder- und Jugendklinik, University Witten/Herdecke
      • Dortmund, Germany, 44137
        • Recruiting
        • Klinikum Dortmund
      • Dresden, Germany, 01307
        • Recruiting
        • University Hospital Dresden
      • Duisburg, Germany, 47055
        • Active, not recruiting
        • Klinikum Duisburg
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitäts-Kinderklinik Düsseldorf
      • Erfurt, Germany, 99089
        • Recruiting
        • HELIOS Klinikum-Erfurt
      • Erlangen, Germany, 91054
        • Recruiting
        • University Hospital Erlangen
      • Essen, Germany, 45147
        • Recruiting
        • University Hospital Essen
      • Frankfurt, Germany, 60590
        • Recruiting
        • University Hospital Frankfurt/Main
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • University Hospital Freiburg
      • Giessen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen und Marburg
      • Greifswald, Germany, 17475
        • Recruiting
        • University Hospital Greifswald
      • Göttingen, Germany, 37075
        • Recruiting
        • Georg-August-Universität Göttingen
      • Halle, Germany, 06120
        • Recruiting
        • University Hospital Halle/Saale
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
          • Stefan Rutkowski, Prof.
          • Phone Number: 58200 +49-40-7410
          • Email: hitchem@uke.de
        • Contact:
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Recruiting
        • Angelika-Lautenschläger-Klinik
      • Heilbronn, Germany, 74078
        • Recruiting
        • Slk-Kliniken
      • Herdecke, Germany, 58313
        • Recruiting
        • Gemeinschaftskrankenhaus Herdecke
      • Homburg, Germany, 66421
        • Recruiting
        • University Hospital Homburg/Saar
      • Jena, Germany, 07740
        • Recruiting
        • University Hopsital Jena
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Stadtisches Klinikum Karlsruhe
      • Kassel, Germany, 34125
        • Active, not recruiting
        • Klinikum Kassel
      • Kiel, Germany, 24105
        • Recruiting
        • UK-SH Campus Kiel
      • Koblenz, Germany, 56073
        • Recruiting
        • Gemeinschaftsklinikum Koblenz-Mayen
      • Krefeld, Germany, 47805
        • Not yet recruiting
        • Helios Klinikum Krefeld
      • Leipzig, Germany, 04103
        • Active, not recruiting
        • University Hospital Leipzig
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
      • Magdeburg, Germany, 39120
        • Recruiting
        • University Hospital Magdeburg
      • Mainz, Germany, 55131
        • Recruiting
        • University Hospital Mainz
      • Mannheim, Germany, 68167
        • Recruiting
        • University Hospital Mannheim
      • Minden, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden
      • München, Germany, 80337
        • Recruiting
        • Universität München - von Haunersches
      • München, Germany, 80804
        • Recruiting
        • Klinikum Schwabing, Pediatric Hospital of Technical University
      • Münster, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster
      • Nuremberg, Germany, 90419
        • Recruiting
        • Cnopf'sche Kinderklinik
      • Oldenburg, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg
      • Regensburg, Germany, 93053
        • Recruiting
        • University Hospital Regensburg
      • Rostock, Germany, 18057
        • Recruiting
        • University Hospital Rostock
      • Sankt Augustin, Germany, 53757
        • Recruiting
        • Asklepios Klinik Sankt Augustin
      • Schwerin, Germany, 19049
        • Recruiting
        • Helios Kliniken Schwerin
      • Stuttgart, Germany, 70176
        • Recruiting
        • Klinikum Stuttgart
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinik Tübingen
      • Ulm, Germany, 89075
        • Recruiting
        • University Hospital Ulm
      • Wiesbaden, Germany, 65199
        • Withdrawn
        • Dr. Horst Schmidt Kliniken
      • Wolfsburg, Germany, 38440
        • Recruiting
        • Klinikum der Stadt Wolfsburg
      • Würzburg, Germany, 97080
        • Recruiting
        • Universotätsklinikum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: 10 years
10 years
Pattern of relapse
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Rutkowski, Prof., Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I-HIT-MED Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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