NCT03615170Unknown不适用
Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Application of circulating tumor DNA detection in diagnosis and treatment of locally advanced rectal cancer. First, to explore the feasibility of ctDNA as a detection index for rectal cancer. Second, evaluate the accuracy of ctDNA detection in rectal cancer. Third, to explore whether ctDNA can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. Fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. Fifth, search for possible recurrence related mutations.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed primary rectal cancer；
- •First treatment；
- •18 years of age or older, male or female；
- •According to the indications of operation, surgical treatment can be carried out；
- •According to the indications of radiotherapy, radiotherapy can be carried out；
- •The physical status score of ECOG was 0~1；
- •Organ function is appropriate;
- •Expected survival time more than 3 months；
- •During the treatment period and 6 months after treatment, contraception was not in lactation；
- •The patient volunteered and signed the informed consent.
排除标准
- •Poor compliance and failure to receive medication or follow up according to plan；
- •There are other serious violations of the programme;
- •At present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research；
- •It has a history of other cancers. Unless the cancer is completely relieved, the disease is not treated for more than 3 years.
结局指标
主要结局
Disease free survival
时间窗: 3 year
Disease free survival
次要结局
未报告次要终点
研究者
研究点 (1)
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