Significance of Circulating Tumor Cells (CTC) Detected by the CTCBIOPSY System as Potential Blood-based Biomarkers in Providing Prognostic and Predictive Information for Surgical Treatment of Gastric and Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
详细描述
Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).
Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.
In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Gastric cancer of stage II/III
排除标准
- •History of malignant tumors
- •Gastric cancer of stage Ⅳ
- •Preoperative neoadjuvant chemotherapy
- •History of upper abdominal surgery
- •Severe other contradictions of surgery
- •Rectal cancer
- •Inclusion Criteria:
- •Primary rectal carcinoma
- •Single lesion
- •No metastasis
- •Sphincter-saving surgery available
- •Exclusion Criteria:
- •History of malignant tumors
- •Acute bowel obstruction, bleeding or perforation
- •Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
- •Severe other contradictions of surgery
结局指标
主要结局
Disease-free survival
时间窗: Two years
次要结局
- Circulating tumor cell (CTC) test(Two years)
研究者
Sanyuan Hu
Dr.& Prof.
Qilu Hospital of Shandong University
