Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma

Ependymoma Clinical Trial

Official title:

Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, Central Nervous System (CNS)- Primitive Neuroectodermal Tumour (PNET), or Ependymoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238899
• Other study ID #: HIT 2000 Interim Register
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: May 28, 2015
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies.

Description:

The Register is based on the study HIT 2000 that recruited patients until 31.12.2011. All german patients with intracranial medulloblastoma, CNS-PNET, ependymoma can be included in the register. Object of the register is to maintain the quality of diagnostic standard by using of central review (Neuroradiology, Pathology, and cranio spinal fluid (CSF) cytology).

Furthermore, the register should enable to continue the collection of epidemiologic data and biological material (tumor material, CSF, and blood) for associated studies.

The register gives recommendations for the therapy of the patients, but these are not mandatory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• age at diagnosis 0-21 years

• histologically proven medulloblastoma, CNS-PNET (incl. pineoblastoma, ependymoblastoma, CNS-neuroblastoma), or ependymoma (WHO II/ III)

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Primitive Neuroectodermal Tumor
• Ependymoma
• Medulloblastoma
• Medulloblastoma, Childhood
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive

Locations

Country	Name	City	State
Germany	University Hospital	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival (EFS)	event free survival probability rates will be calculated	up to 10 years	No