跳至主要内容
临床试验/NCT05371873
NCT05371873进行中(未招募)不适用

A Prospective Study of Early Warning and Predictive Indicators Related to the Individualized Staging and Prognosis in Liver Cancer Patients

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
250
试验地点
1
主要终点
MRD monitor

研究概览

简要总结

Liver cancer is one of the most common malignant tumors worldwide with high morbidity and mortality, and hepatocellular carcinoma (HCC) is the main histological subtype. So far, liver resection is the most effective treatment but the postoperative recurrence rate is high at five years, and the prognosis is difficult to estimate. Microvascular invasion (MVI) and postoperative minimal residual disease (MRD) are crucial prognostic factors for patients undergoing hepatectomy. Although many laboratory and imaging methods have been established to estimate the recurrence risk, their stability and accuracy are still not high. To date, no unified conclusion is achieved. It's eagerly to screen out a batch of individualized staging and prognosis-related biological indicators for early warning and prediction of prognosis, having good stability and high precision. Circulating cell-free DNA (cfDNA) molecular detection technology is an emerging detection technology of tumor gene profiling in recent years, which can be used to predict and monitor tumor recurrence. In this study, by detecting genomic chromosomal abnormalities in plasma and tumor tissues of patients before and after surgery, the investigators hope to construct a preoperative MVI prediction model and a postoperative MRD monitoring model, so as to provide reference for the precise treatment of HCC.

详细描述

MVI and MRD confirmed by postoperative pathology are important prognostic factors for recurrence after liver resection, but current assessment methods have low sensitivity and specificity. cfDNA refers to the partially degraded endogenous DNA in the circulating blood that is free from the extracellular part of the body. When derived from dead and lysed tumor cells, it is called ctDNA, having a high chromosomal instability and relating to the tumor subtype and process. By low coverage whole genome sequencing, cfDNA and ctDNA in plasma were extracted and sequenced and chromosomal instability analysis is realized through UCAD pipeline. Therefore, the investigators can predict the trend of tumor by detecting cfDNA in patients, indicate MVI and MRD, carry out individualized staging of patients, predict recurrence and prognosis, and verify the prediction efficiency through follow-up, so as to establish corresponding prediction models.

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

入选标准

  • 18 to 80 years old;
  • clinical diagnosis of liver cancer;
  • intend to perform surgical treatment;
  • postoperative pathological diagnosis of hepatocellular carcinoma;
  • signed informed consent.

排除标准

  • Not diagnosed with liver mass;
  • Not undergo liver resection;
  • Postoperative pathological diagnosis of non-hepatocellular carcinoma;
  • Under the age of 18 or over 80;
  • Concomitant pregnancy;
  • Concomitant serious complications, including end-stage lung disease, unstable coronary heart disease or congestive heart failure grade 3-4, chronic kidney disease stage 4-5, cirrhosis (Child-Pugh) grade C, immunodeficiency;
  • Incomplete data records.

结局指标

主要结局

MRD monitor

时间窗: 4 years

Monitor postoperative MRD in postoperative patients and predict the recurrence risk and prognosis by detecting chromosomal abnormalities in peripheral blood cfDNA.

MVI model

时间窗: 4 years

Establish a preoperative prediction model of MVI by detecting chromosomal abnormalities in peripheral blood cfDNA

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

xiaqi

Director

First Affiliated Hospital of Zhejiang University

研究点 (1)

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