International HIT-MED Registry (I-HIT-MED)
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|ClinicalTrials.gov Identifier: NCT02417324|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2015
Last Update Posted : April 12, 2022
|Condition or disease|
|Childhood Brain Tumor|
The following patients can be included in this registry:
Children and adults with
- Medulloblastoma (MB)
- CNS-primitive neuroectodermal tumours (CNS-PNET) including CNS neuroblastoma, CNS ganglioneuroblastoma, Medulloepithelioma, Ependymoblastoma, CNS-PNET not otherwise specified (NOS)
- Pineal parenchymal tumour of intermediate differentiation
- Papillary tumour of the pineal region Who are not included in prospective clinical trials for these conditions
The objectives of this registry are
- To evaluate clinical data on the epidemiology of the above mentioned CNS-neoplasms, and the use and outcome of different treatment regimens, for patients who cannot be included in prospective trials.
- To provide guidelines to establish, maintain and improve systems for quality assurance in the diagnostic assessments and treatment of brain tumours.
To collect biological specimens (tumour, cerebrospinal fluid (CSF), peripheral blood) and perform comprehensive biological studies with the aim to improve our understanding of these diseases and their aetiology, to improve therapy stratification and to improve or develop new treatment options.
- To collect clinical data for cooperative scientific projects (e.g. new follow-up studies, studies on quality of survival, neuropsychology etc.)
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||International HIT-MED Registry (I-HIT-MED) for Children, Adolescents, and Adults With Medulloblastoma, Ependymoma, Pineoblastoma, CNS-primitive Neuroectodermal Tumours|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2029|
|Estimated Study Completion Date :||December 2029|
- 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.
- Pattern of relapse [ Time Frame: 10 years ]
- Overall survival [ Time Frame: 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417324
|Principal Investigator:||Stefan Rutkowski, Prof.||Universitätsklinikum Hamburg-Eppendorf|