Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- To determine if there is a link between EMVI status and ctDNA
研究概览
简要总结
This study does not involve randomization or treatment. Eligible patients have colorectal adenocarcinoma with no metastases eligible for curative surgery. A pre operative staging scan must have been completed within 6 weeks prior to surgery. Two x 20ml blood samples will be taken from each patient, one prior to and one during or within 24hrs after surgery. Patients are annually followed up to 3 years.
详细描述
A multicentre observational study, ctDNA aims to provide the evidence base for metatstatic disease being caused by vascular methods of spread by determining if there is a link between EMVI status and ctDNA
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a biopsy-confirmed colorectal adenocarcinoma
- •Is eligible for curative surgery
- •Has no metastatic disease on CT scan
- •Has completed pre-operative staging scan within six weeks prior to surgery
- •Have provided written informed consent to participate in the study
- •Be aged 16 years or over
排除标准
- •Have metastatic disease (including resectable liver metastases)
- •Have a synchronous second malignancy
- •Are contraindicated for any imaging able to determine EMVI status
结局指标
主要结局
To determine if there is a link between EMVI status and ctDNA
时间窗: Up to 2 years
Proportion of patients who are EMVI positive demonstrating higher % mutation frequency of circulating cell-free and tumour specific DNA compared with patients who are EMVI negative.
次要结局
- To investigate whether ctDNA levels change during surgery according to EMVI status(Up to 2 years)
- To investigate the effect of ctDNA status on patient survival outcomes(At 1, 2 and 3 years)