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临床试验/NCT02955173
NCT02955173已完成不适用

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

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 467 人开始时间: 2016年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanyuan Hu

Dr.& Prof.

Qilu Hospital of Shandong University

研究点 (1)

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