Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759858
• Other study ID #: 2022-0856
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Sheng Yan, Doctor
• Phone: 13957161680
• Email: shengyan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Hepatocellular carcinoma confirmed by pathology;

2. The patient has no combined organic diseases of heart, lung, and kidney, etc;

3. No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors;

4. The patient has successfully completed the operation and has complete clinical information and pathological data.

Exclusion Criteria:

1. Patients who have previous history of other tumors or have undergone upper abdominal surgery;

2. Patients with multiple lesions and distant metastasis;

3. Patients who are complicated with organic diseases of important organs such as heart, lung and kidney and cannot tolerate surgery;

4. Patients who are more than 75 years old or less than 18 years old.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• None of intervention
None of the interventions was applied.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key gene differences in hepatocellular carcinoma	Key gene differences in hepatocellular carcinoma explored by RNA-seq.	Through study completion, an average of 1 year.
Primary	Overall survival	The time from the beginning of treatment to death (for any reason).	Through study completion, up to 5 years.
Primary	Disease-free survival	The time from the beginning of treatment to death (for any reason).	Through study completion, up to 5 years.
Secondary	The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.	The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.	Through study completion, up to 5 years.