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临床试验/NCT04688606
NCT04688606Unknown不适用

Zhongnan Hospital of Wuhan University

Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Clinical detection of circulating tumor cells

研究概览

简要总结

Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.

详细描述

  1. Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.
  2. Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.
  3. To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
  • Age 18-75 years old;
  • ASA (risk of anesthesia) score I-II;
  • The ECOG score is 0-1;

排除标准

  • In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
  • Patients with extrahepatic or lymphatic metastasis;
  • Patients who still have serious complications 4 weeks after surgery;
  • Patients who cannot provide informed consent;

结局指标

主要结局

Clinical detection of circulating tumor cells

时间窗: 2020.01.20-2021.02.28

To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation

次要结局

  • Circulating tumor cell function detection and verification(2020.03.01-2021.05.20)

研究者

发起方
Zhongnan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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