Analysis of Circulating Tumor Markers in Blood - ALCINA 5
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers.
研究概览
简要总结
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.
详细描述
The new major challenge in research focuses on the rapid evaluation of circulating biomarker candidates, which could replace or complement molecular analyses of tumor tissue obtained through biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.
The study ALCINA 5 relies exactly on the principle of small cohorts based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy. Which cohort correspond each to a clinical situation and/or a technique of different implemented detection. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
- •18 years old or higher ?
- •Patient who has provided informed, written, and explicit consent,
- •Patient affiliated with a French Social Protection System.
- •In the case of a tumor biopsy:
- •Tumor considered as accessible by biopsy,
- •Normal hemostasis assessment (PT, APTT, platelets),
- •No anticoagulant or antiaggregant treatment for the biopsy.
排除标准
- •Pregnant woman and/or breast-feeding,
- •Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- •Private persons of freedom or under guardianship,
- •Patient with a history of other invasive cancers within the 5 years preceding inclusion.
研究组 & 干预措施
COHORT 1 - CURE
Patients with histologically proven metastatic non-small cell lung carcinoma eligible for immunotherapy
干预措施: Blood sampling C1 (Biological)
结局指标
主要结局
All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers.
时间窗: 10 years
Success rate of the detection technique used (the criterion will be detailed according to the biomarker evaluated, in each of the cohorts)
次要结局
- COHORT 1 - CURE : to define a liquid biopsy signature for predicting therapeutic response from samples taken before initiation of immunotherapy (T1).(4 years)