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临床试验/NCT06794736
NCT06794736招募中不适用

STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio4 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年11月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
4
主要终点
Progression Free Survival (PFS)

研究概览

简要总结

The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.

Participants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy/progression) and diagnosis (astrocytoma/oligodendroglioma and grade).

Critical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.

研究设计

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

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

  • Radiological diagnosis of brain tumor compatible with lower grade glioma
  • Full clinical history

排除标准

  • Current pregnancy or lactation
  • Patients not able to provide informed consent
  • Retrospective Cohort of FFPE samples:
  • Inclusion Criteria:
  • Confirmed diagnosis of lower grade glioma
  • Full clinical and radiological history

结局指标

主要结局

Progression Free Survival (PFS)

时间窗: (up to 180 months)

time from surgery to evidence of radiological progression at MRI

Overall Survival (OS)

时间窗: (up to 180 months)

Time from surgery to tumor-related death

次要结局

  • Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)(From date of surgery to date of complete diagnosis (weeks))
  • Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)(From surgery to complete history-molecular diagnosis (weeks))

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (4)

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