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

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ClinicalTrials.gov Identifier: NCT02417324
Recruitment Status : Recruiting
First Posted : April 15, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
The I-HIT-MED registry registers clinical of children and adults with medulloblastoma, ependymoma, pineoblastoma, or CNS-primitive neuroectodermal tumour (CNS-PNET) 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.

Condition or disease
Childhood Brain Tumor

Detailed Description:

The following patients can be included in this registry:

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

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.)


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2019
Estimated Study Completion Date : December 2024





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pattern of relapse [ Time Frame: 10 years ]
  2. Overall survival [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Tumour samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Stefan Rutkowski, Prof. +49-40-7410 ext 58200 hitchem@uke.de
Contact: Martin Mynarek, MD +49-40-7410 ext 58200 m.mynarek@uke.de

  Show 57 Study Locations
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Rutkowski, Prof. Universitätsklinikum Hamburg-Eppendorf

Additional Information:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02417324     History of Changes
Other Study ID Numbers: I-HIT-MED Registry
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
medulloblastoma
ependymoma
pineoblastoma
CNS-PNET

Additional relevant MeSH terms:
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Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue