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Completed

NCT Number: NCT00920335

Adult Intracranial Ependymoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tumoral sample

Other

Ependymoma tumoral sample

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 15, 2009
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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