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临床试验/NCT05259332
NCT05259332Unknown不适用

Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
85
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).

Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
  • At least one postoperative follow-up visit.
  • Adult patients (>18 yo) at the time of the intervention.
  • Surgical excision.

排除标准

  • History of meningioma in the same location.
  • Neo-adjuvant treatment.
  • Absence of non-objection form.

结局指标

主要结局

Progression-free survival

时间窗: through study completion an average of 5 years.

Progression being defined by a growth (mm3) of the tumor objectified by imaging.

次要结局

  • Tumor volume assessed by imaging pre- and post-operative(before and within 3 months after surgery)
  • mRNA quantities of transcripts of interest(through study completion, an average of 1 year)
  • Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.(through study completion, an average of 1 year)
  • Radiotherapy-induced toxicity(within 5 years after radiotherapy)
  • Dose of corticosteroids before and after radiotherapy(within 6 months before and after radiotherapy)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume GAUCHOTTE

University professor and Hospital practitioner

Central Hospital, Nancy, France

研究点 (1)

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