Adult Intracranial Ependymoma
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Intracranial Ependymoma |
Other: tumoral sample |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization |
- The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 192 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Other: tumoral sample
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: philippe METELLUS | philippe.metellus@ap-hm.fr |
| France | |
| Assistance Publique Hopitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: PHILIPPE METELLUS | |
| Principal Investigator: PHILIPPE METELLUS | |
| Principal Investigator: | philippe METELLUS | Assistance Publique Hopitaux De Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille, Direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT00920335 History of Changes |
| Other Study ID Numbers: | 2008-25, 2008-A01289-46 |
| Study First Received: | May 4, 2009 |
| Last Updated: | August 3, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
Adult intracranial ependymoma |
Additional relevant MeSH terms:
|
Ependymoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013