跳至主要内容
临床试验/NCT05759858
NCT05759858招募中不适用

A Single-center Study of the Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Disease-free survival

研究概览

简要总结

To explore the key genes of human and mouse hepatocellular carcinoma, identify the key genes and prognostic markers, and develop small molecule drugs targeting the key genes to treat hepatocellular carcinoma.

详细描述

Hepatocellular carcinoma (HCC) is one of the most common solid malignant tumors and the main cause of cancer-related deaths worldwide. About 750000 new cases of liver cancer are diagnosed every year, half of which are in China. The onset of liver cancer is relatively hidden, and there are generally no symptoms in the early stage. When the patient has obvious clinical symptoms, the disease often belongs to the middle and late stages. The first symptom of liver cancer is liver pain, followed by upper abdominal mass. Some patients also showed some complications of liver cirrhosis, such as black stool, hematemesis, jaundice, liver coma, ascites, etc. A few patients were hospitalized due to symptoms caused by metastatic lesions.

At present, the accuracy of detecting HCC is poor, and the common indicators such as AFP have a certain time lag, which cannot detect patients with liver cancer early. thus, there is an urgent need for a new biomarker for the diagnosis and prognosis of liver cancer. Our research focuses on exploring the key genes of human and mouse hepatocellular carcinoma, identifying the key genes and prognostic markers by means of transcriptome sequencing, and developing small molecule drugs targeting the key genes.

High-throughput sequencing technology was used for sequencing analysis to reflect the expression level of mRNA, small RNA, noncoding RNA, or some other markers. After finding the gene difference between the liver cancer sample and the para-cancer sample, relevant immunohistochemical staining was performed to analyze the overall survival time difference between the patients with high-expression genomes and the patients with low-expression genomes. Follow-up cell and animal experiments were carried out to further verify the effect of target genes on the occurrence and development of liver cancer. In the first month after the operation, the patient was followed up at the outpatient clinic to understand the general situation of the patient after the operation, such as diet and appetite, symptom control, such as fever, abdominal pain, and drainage tube removal. One year and three years after the operation, our center will follow up on the patients and re-hospitalization if necessary.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hepatocellular carcinoma confirmed by pathology;
  • The patient has no combined organic diseases of heart, lung, and kidney, etc;
  • No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors;
  • The patient has successfully completed the operation and has complete clinical information and pathological data.

排除标准

  • Patients who have previous history of other tumors or have undergone upper abdominal surgery;
  • Patients with multiple lesions and distant metastasis;
  • Patients who are complicated with organic diseases of important organs such as heart, lung and kidney and cannot tolerate surgery;
  • Patients who are more than 75 years old or less than 18 years old.

结局指标

主要结局

Disease-free survival

时间窗: Through study completion, up to 5 years.

The time from the beginning of treatment to death (for any reason).

Key gene differences in hepatocellular carcinoma

时间窗: Through study completion, an average of 1 year.

Key gene differences in hepatocellular carcinoma explored by RNA-seq.

Overall survival

时间窗: Through study completion, up to 5 years.

The time from the beginning of treatment to death (for any reason).

次要结局

  • The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.(Through study completion, up to 5 years.)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验