Adult Intracranial Ependymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920335
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
Adult intracranial ependymoma is a relatively rare brain tumour entity, accounting for 2-5% of all intracranial neoplasms. The pertinent prognostic factors as well as the pattern of recurrence remain to be elucidated. According to several recent reports, the prognostic value of Karnofski performance status, tumour location, the extent of surgical removal, histological grade and even postoperative radiotherapy remain controversial. As a consequence, optimal therapeutic management of adult intracranial ependymomas remains an ongoing debate. For this reason, a retrospective study conducted by the French society of neurosurgery (SFNC), neuropathology (SFNP) and the association of the neuro-oncologists of French expression (ANOCEF) was undertaken and allowed to collect 258 cases coming from 25 centers, initially diagnosed as intracranial ependymomas between 1990 and 2004. Clinical and follow-up data of these patients are known and the paraffin embedded samples as well as the frozen tissues available have been centralized. Central pathological review of these 258 cases was conducted by two senior neuropathologists and confirmed the diagnosis of ependymoma in 152 cases, thus constituting the most important series of the literature. Few molecular studies were carried out on ependymomas. The investigators have the opportunity, based on this important series, to determine the clinicopathological criteria and the molecular markers who will allow a better characterization of the diagnosis and the prognosis of these tumors.

Condition or disease Intervention/treatment Phase
Intracranial Ependymoma Other: tumoral sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization
Study Start Date : March 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: tumoral sample
    Ependymoma tumoral sample

Primary Outcome Measures :
  1. The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Firstly to identify reliable molecular markers of the diagnosis of adult intracranial ependymomas and, secondly, to seek a molecular signature selectively expressed in sub-groups of ependymomas according to topography, age and histological grading. [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis later(posterior) than January, 1990
  • Diagnosis previous to June, 2004
  • Available postoperative MRI at the not dead patients during operating
  • Diagnosis of EICA held(retained) after centralized second reading
  • Absence of histories of radiotherapy and\or chemotherapy for a brain damage

Exclusion Criteria:

  • Diagnosis previous to January, 1990
  • Diagnosis later(posterior) than June, 2004 ·
  • Diagnosis of EICA not held(retained) after centralized second reading
  • Histories of radiotherapy and\or chemotherapy for a brain damage

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 identifier (NCT number): NCT00920335

Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: philippe METELLUS Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT00920335     History of Changes
Other Study ID Numbers: 2008-25
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
Adult intracranial ependymoma

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