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

NCT ID: NCT02417324

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Brain Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Rutkowski, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Aachen

Aachen, , Germany

Site Status RECRUITING

Klinikum Augsburg

Augsburg, , Germany

Site Status RECRUITING

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status RECRUITING

Charite Campus, University of Berlin

Berlin, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Bielefeld

Bielefeld, , Germany

Site Status RECRUITING

Klinikum Braunschweig

Braunschweig, , Germany

Site Status RECRUITING

Klinikum Bremen-Mitte

Bremen, , Germany

Site Status RECRUITING

Klinikum Chemnitz

Chemnitz, , Germany

Site Status RECRUITING

University Hospital Cologne

Cologne, , Germany

Site Status NOT_YET_RECRUITING

Carl-Thiem-Klinikum Cottbus

Cottbus, , Germany

Site Status RECRUITING

Vestische Kinder- und Jugendklinik, University Witten/Herdecke

Datteln, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum Dortmund

Dortmund, , Germany

Site Status RECRUITING

University Hospital Dresden

Dresden, , Germany

Site Status RECRUITING

Klinikum Duisburg

Duisburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitäts-Kinderklinik Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

HELIOS Klinikum-Erfurt

Erfurt, , Germany

Site Status RECRUITING

University Hospital Erlangen

Erlangen, , Germany

Site Status RECRUITING

University Hospital Essen

Essen, , Germany

Site Status RECRUITING

University Hospital Frankfurt/Main

Frankfurt, , Germany

Site Status RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg

Giessen, , Germany

Site Status RECRUITING

Georg-August-Universität Göttingen

Göttingen, , Germany

Site Status RECRUITING

University Hospital Greifswald

Greifswald, , Germany

Site Status RECRUITING

University Hospital Halle/Saale

Halle, , Germany

Site Status RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Angelika-Lautenschläger-Klinik

Heidelberg, , Germany

Site Status RECRUITING

SLK-Kliniken

Heilbronn, , Germany

Site Status RECRUITING

Gemeinschaftskrankenhaus Herdecke

Herdecke, , Germany

Site Status RECRUITING

University Hospital Homburg/Saar

Homburg, , Germany

Site Status RECRUITING

University Hopsital Jena

Jena, , Germany

Site Status RECRUITING

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status RECRUITING

Klinikum Kassel

Kassel, , Germany

Site Status ACTIVE_NOT_RECRUITING

UK-SH Campus Kiel

Kiel, , Germany

Site Status RECRUITING

Gemeinschaftsklinikum Koblenz-Mayen

Koblenz, , Germany

Site Status RECRUITING

HELIOS Klinikum Krefeld

Krefeld, , Germany

Site Status NOT_YET_RECRUITING

University Hospital Leipzig

Leipzig, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

University Hospital Magdeburg

Magdeburg, , Germany

Site Status RECRUITING

University Hospital Mainz

Mainz, , Germany

Site Status RECRUITING

University Hospital Mannheim

Mannheim, , Germany

Site Status RECRUITING

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status RECRUITING

Universität München - von Haunersches

München, , Germany

Site Status RECRUITING

Klinikum Schwabing, Pediatric Hospital of Technical University

München, , Germany

Site Status RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status RECRUITING

Cnopf'sche Kinderklinik

Nuremberg, , Germany

Site Status RECRUITING

Klinikum Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

University Hospital Regensburg

Regensburg, , Germany

Site Status RECRUITING

University Hospital Rostock

Rostock, , Germany

Site Status RECRUITING

Asklepios Klinik Sankt Augustin

Sankt Augustin, , Germany

Site Status RECRUITING

Helios Kliniken Schwerin

Schwerin, , Germany

Site Status RECRUITING

Klinikum Stuttgart

Stuttgart, , Germany

Site Status RECRUITING

Universitätsklinik Tübingen

Tübingen, , Germany

Site Status RECRUITING

University Hospital Ulm

Ulm, , Germany

Site Status RECRUITING

Dr. Horst Schmidt Kliniken

Wiesbaden, , Germany

Site Status WITHDRAWN

Klinikum der Stadt Wolfsburg

Wolfsburg, , Germany

Site Status RECRUITING

Universotätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stefan Rutkowski, Prof.

Role: CONTACT

+49-40-7410 ext. 58200

Martin Mynarek, MD

Role: CONTACT

+49-40-7410 ext. 58200

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stefan Rutkowski, Prof.

Role: primary

+49-40-7410 ext. 58200

Martin Mynarek, MD

Role: backup

+49-40-7410 ext. 58200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I-HIT-MED Registry

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

18F-Fluciclovine PET-MRI in High-grade Glioma
NCT05553041 RECRUITING EARLY_PHASE1
MEDIR Medulloblastome
NCT01197924 UNKNOWN