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临床试验/NCT00920335
NCT00920335已完成不适用

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

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
192
试验地点
1
主要终点
The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 3 years

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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