Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 14
- 主要终点
- Proportion of patients presenting at least one genomic alteration
研究概览
简要总结
This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.
In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.
Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.
详细描述
The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.
The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.
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
- 否
入选标准
- •Age ≥ 18 years,
- •Histology: solid malignant tumor or hematological malignancy,
- •Deleted MSA9
- •Deleted MSA9,
- •Deleted MSA9,
- •Deleted MSA9,
- •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
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Deleted MSA9
- •Individuals deprived of liberty or placed under guardianship
- •Pregnant or breast feeding women,
- •Previous enrolment in the present study.
研究组 & 干预措施
Experimental
Newly obtained biopsy and Blood samples collection
干预措施: Newly obtained biopsy and Blood samples collection (Procedure)
结局指标
主要结局
Proportion of patients presenting at least one genomic alteration
时间窗: 1 month
The proportion of patients with advanced cancer presenting at least one genomic alteration will be described in the NGS population and reported using the proportion. The 95% two-sided confidence limits (95%CI) will be provided for the calculated rate (binomial law).
次要结局
- - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)(Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months)
- Rate of molecular screening failure(Molecular screening failure will be assessed at 1 month)
- Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.(Safety will be assessed 1 month after biopsy)