Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Proportion of patients who consent to participate in the study
研究概览
简要总结
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.
详细描述
Implementation of a translational research project is part of the Cancer Plan 2014-2019 and its axis 5 "Advancing clinical and translational research in oncology", and more precisely Action 5.1.
The national health strategy launched by the Minister of Health and the Minister of Research will allow a better integration between research, innovation, medicine and care for the benefit of patients and society.
Moreover, knowledge of mechanisms involved in the phenomena of tumor invasion, metastatic dissemination, resistance to treatment and companion testing is crucial for the emergence of new biomarkers and therapeutic innovation.
However, the study of the earliest phases of tumorigenesis as well as of the advanced stages of the disease are currently limited by the low availability of blood and tissue samples combined with quality and reliable clinical data.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients.
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> at 18 years old,
- •Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,
- •Patient in ICM at diagnosis
- •a digestive cancer (esophagus, stomach, pancreas, colon, rectum, anal canal) or
- •gynecological cancer (ovary, endometrium, cervix) or
- •breast cancer or
- •Naïve patient of any treatment for the present cancer,
- •Patient requiring treatment involving at least one (or more) tumor surgery (s)
- •Patient who has accepted supplementary blood samples,
- •Patient having given his informed, written and express consent.
排除标准
- •Patient not affiliated to a social protection scheme,
- •Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,
- •Pregnant and / or nursing women,
- •Subject under tutelage, curatorship or safeguard of justice,
- •Patient in an emergency situation.
研究组 & 干预措施
Biological collection
samples of different natures:
- Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery.
- Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out.
In parallel to this biological collection, standardized clinical data will be entered into a database
干预措施: biological collection (Biological)
结局指标
主要结局
Proportion of patients who consent to participate in the study
时间窗: through study completion, an average of 1 year
the proportion of patients who consent to participate in the study among the screened patients
次要结局
未报告次要终点