Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of patients who gave their consent to participate in the study
研究概览
简要总结
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.
详细描述
In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.
Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.
Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.
Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.
Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.
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
- •Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
- •Age > 18 years
- •Signed informed consent
排除标准
- •Patient not affiliated to Social Protection system
- •Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- •Patient under guardianship
结局指标
主要结局
Proportion of patients who gave their consent to participate in the study
时间窗: Until the study completion : 66 months
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