NCT02417324 International HIT-MED Registry (I-HIT-MED)
| NCT ID | NCT02417324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Childhood Brain Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2015-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2015-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Stefan Rutkowski, Prof.
PRINCIPAL INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT02417324 clinical trial?
This trial is open to participants of all sexes, studying Childhood Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02417324 currently recruiting?
Yes, NCT02417324 is actively recruiting participants. Contact the research team at hitchem@uke.de for enrollment information.
Where is the NCT02417324 trial being conducted?
This trial is being conducted at Aachen, Germany, Augsburg, Germany, Berlin, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT02417324 clinical trial?
NCT02417324 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Stefan Rutkowski, Prof. at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 500 participants.