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Adult Intracranial Ependymoma

Primary Purpose

Intracranial Ependymoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tumoral sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Ependymoma focused on measuring Adult intracranial ependymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Outcomes

Primary Outcome Measures

The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas.

Secondary Outcome Measures

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.

Full Information

First Posted
May 4, 2009
Last Updated
February 24, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00920335
Brief Title
Adult Intracranial Ependymoma
Official Title
Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Ependymoma
Keywords
Adult intracranial ependymoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
tumoral sample
Intervention Description
Ependymoma tumoral sample
Primary Outcome Measure Information:
Title
The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
philippe METELLUS
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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Adult Intracranial Ependymoma

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