NCT02417324

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

57 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2015Dec 2029

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

14.9 years

First QC Date

February 4, 2015

Last Update Submit

November 27, 2025

Conditions

Keywords

medulloblastomaependymomapineal tumourCPT

Outcome Measures

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.

    10 years

Secondary Outcomes (2)

  • Pattern of relapse

    10 years

  • Overall survival

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

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

Biospecimen

Retention: SAMPLES WITH DNA

Tumour samples

MeSH Terms

Conditions

MedulloblastomaEpendymomaPinealoma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Stefan Rutkowski, Prof.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Rutkowski, Prof.

CONTACT

Martin Mynarek, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

April 15, 2015

Study Start

January 1, 2015

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations