The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).
详细描述
This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female ≥ 18 years of age on the day of signing informed consent.
- •Patients must have histologically confirmed stage II or IIIcolorectal cancer.
- •Patients must receive radical resection.
- •Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
排除标准
- •Patient has severe anemia.
- •Patients received neoadjuvant treatment.
- •Patients received blood transfusion two weeks before or during the surgical resection.
- •Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject
结局指标
主要结局
Disease Free Survival
时间窗: Two years
次要结局
- Overall survival(Two years)
研究者
Xiaojian Wu
Vice President
Sixth Affiliated Hospital, Sun Yat-sen University