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

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: Recruiting
• Conditions: Childhood Brain Tumor

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: Observational
• Enrollment (Estimated): 500

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event free survival	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

Outcome Measure	Time Frame
Overall survival	10 years
Pattern of relapse	10 years

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Stefan Rutkowski, Prof., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimated): April 15, 2015

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: medulloblastoma; ependymoma; CPT; pineal tumour
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neuroectodermal Tumors, Primitive; Central Nervous System Neoplasms; Brain Neoplasms; Ependymoma; Medulloblastoma; Pinealoma
• Other Study ID Numbers: I-HIT-MED Registry