Gustave Roussy Cancer Profiling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 4
- 主要终点
- Number of patients presenting at least one targetable genomic alteration
研究概览
简要总结
The objective of STING study is to perform high throughput molecular analysis (next generation sequencing +/- immunological profiling) to estimate the proportion of patients with cancer presenting at least one targetable genomic alteration.
详细描述
STING is a biology driven, multicenter study designed to identify actionable molecular alterations in cancer patients and to explore mechanisms of sensitivity and resistance to anti-cancer treatment
- In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling
- Patients included in the STING study and for whom a targetable genomic alteration had been identified might be subsequently included in a clinical trial running at Gustave Roussy or another participating center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age ≥ 18 years
- •Histology: solid malignant tumor or hematological malignancy.
- •Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- •Voluntary signed and dated written informed consent prior to any study specific procedure.
排除标准
- •Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- •Pregnant or breast-feeding women
- •Minors (Age < 18 years)
研究组 & 干预措施
solid tumor or hematological malignancy
干预措施: Biopsy (Procedure)
结局指标
主要结局
Number of patients presenting at least one targetable genomic alteration
时间窗: 2 months after the last enrollment
Number of patients presenting at least one targetable genomic alteration
Proportion of patients presenting at least one targetable genomic alteration
时间窗: 2 months after the last enrollment
Proportion of patients presenting at least one targetable genomic alteration
次要结局
- Progression-free survival(24 months post treatment after the last enrollment)
- Overall survival(24 months post treatment after the last enrollment)
- Rate of molecular profiling information including utilization of information for standard regimens or clinical trials of molecularly targeted therapies(2 months after the last enrollment)
- Objective response rate(24 months post treatment after the last enrollment)