SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 3,750
- 试验地点
- 1
- 主要终点
- the primary endpoint is the identification of cases with evidence of loss of the product of one of the four main MMR genes on tumour histology.
研究概览
简要总结
the principal research objective is to form a database of tissue samples from patients with colorectal (bowel) cancer. The tissue samples that will be used for this research will have already been taken for diagnostic or therapeutic reasons. We will also be asking for consent for a research blood sample. The database will be used to improve our understanding of the molecular genetics and gene expression patterns in colorectal cancer.
详细描述
All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study. This will include patients both with early and advanced disease, provided they give informed consent. They will give written consent to participate, to include consent for analysis of existing tumour tissue and consent for collection of demographic and clinicopathological data relating to their case and its future outcome, and consent for a blood sample to be taken for research purposes. Additionally, old samples of material surplus to clinical requirements may be collected without specific consent if there is no possibility that it would affect the patient's interest (eg the patient has died).
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
- •adults who have a terminal illness
- •18 and over
- •confirmed diagnosis of colorectal carcinoma
- •ability to give informed consent
- •paraffin embedded histological material available for analysis
排除标准
- •medical or psychiatric conditions
- •impairing ability to give informed consent
结局指标
主要结局
the primary endpoint is the identification of cases with evidence of loss of the product of one of the four main MMR genes on tumour histology.
次要结局
- Secondary outcome measure is the survival and response to treatment of the identified cases.