Clinical trial NCT00920335: Adult Intracranial Ependymoma
Official title: Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Ependymoma
Keywords: Adult intracranial ependymoma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: philippe METELLUS
role: PRINCIPAL_INVESTIGATOR
References: