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