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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00920335
Other study ID # 2008-25
Secondary ID 2008-A01289-46
Status Completed
Phase N/A
First received May 4, 2009
Last updated February 24, 2014
Start date March 2009
Est. completion date July 2013

Study information

Verified date February 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 192
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 ยท

- Diagnosis of EICA not held(retained) after centralized second reading

- Histories of radiotherapy and\or chemotherapy for a brain damage

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
tumoral sample
Ependymoma tumoral sample

Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas. 3 years No
Secondary 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. 3 years No