Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- In vitro analysis of chemotherapy responses
研究概览
简要总结
In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases (lung and liver metastases), treatment with chemotherapy is necessary but not end in success in 10% of cases. The development of techniques for administering personalized treatment becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these patients and evaluating the effect of chemotherapy on these could be made for each patient. In France, the company develops Oncomedics these tests.
This is a pilot study that will make a first evaluation under actual conditions of chimio-oncogramme.
详细描述
A fragment of colon tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with colon carcinoma metastatic (stage 4). In parallel and systematically: analysis by the pathologist of a histological section.
- Culturing the cells obtained from the tumor by Oncomedics fragment in a defined medium and provided for enriching tumor cells compared to stromal cells.
- Maintaining the cells in culture for 7 days.
- Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).
- For each chemotherapy tested, measuring the proportion of dead cells / total cells.
- Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.
- At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient's response to (x) the same (s) chemotherapy (s).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy
- •targets must be measurable tumor lesions (RECIST)
- •patient has not expressed opposition to the use of their residual tumor
排除标准
- •Against-formal indication to an indispensable para-clinical examination of the patient monitoring
- •Use of chemotherapy, hormone therapy or concomitant radiotherapy
- •Cons-indication for chemotherapy
- •Are pregnant, nursing or lack of contraception for women of childbearing age.
结局指标
主要结局
In vitro analysis of chemotherapy responses
时间窗: 7 days
Evaluate the predictive value of chemo-oncogramme on the patient's response to the same (s) chemotherapy (s)
次要结局
- quality of life(7 days)