A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The study is a real-world observational clinical study. Patients diagnosed as colorectal cancer through histopathology were screened and enrolled. Before anti-tumor treatment, colonoscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in colorectal cancer treatment and drug susceptibility outcomes.
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
- •Male or female, aged ≥ 18 and ≤80;
- •Patients with colorectal cancer diagnosed by histopathology;
- •Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
- •Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
- •Patients who sign the informed consent form, and are able to comply with the study period treatment process.
排除标准
- •Inability to follow the research protocol;
- •Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
- •Concomitant contraindications to chemotherapy;
- •pregnant or lactating women;
- •Patients deemed inappropriate by investigators.
结局指标
主要结局
Disease-free survival
时间窗: From date of surgery until the date of first documented recurrence，up to 3 years
An Indicator of efficacy of postoperative adjuvant therapy
Sensitivity
时间窗: Through study completion, an average of 1 year
Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as apercentage of the cases that are effective in clinical evaluation
Specificity
时间窗: Through study completion, an average of 1 year
Cases in which drug susceptibility results are resistance to the antineoplastic regimen as apercentage of the cases that are ineffective in clinical evaluation
次要结局
未报告次要终点
研究者
Funan Liu
professor
China Medical University, China