A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Liver Cancer

Recruiting

• Conditions: Liver Cancer; Liver Cirrhosis; Hepatitis; Fatty Liver
• Interventions: Diagnostic Test: Proteomics technology and liquid biopsy

• Registration Number: NCT05719480
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The incidence of liver cancer in China shows a clear clinical path of hepatitis/fatty liver liver cirrhosis liver cancer. The dynamic changes of the internal environment on this pathway are important clues for early detection, diagnosis and even cure of liver cancer. The investigators carried out this study to investigate the changes of plasma and urine metabolites in different liver diseases during the occurrence and development of liver cancer.

Detailed Description

The process of liver cancer transformation is complex, so it is particularly important to explore the relationship between various liver diseases on its clinical pathway. Therefore, the investigators carried out this study to explore the changes of plasma and urine metabolites under different liver disease conditions during the development of liver cancer.

(1) Retrospective cohort: 600 patients were recruited, including 120 patients with hepatitis, 120 patients with cirrhosis, 120 patients with fatty liver, 120 patients with liver cancer, and 120 healthy people.,(2) Prospective cohort: 1400 patients were recruited, including 280 hepatitis patients, 280 cirrhosis patients, 280 fatty liver patients, 280 liver cancer patients, and 280 healthy people. During the course of the study, the subjects will not be given or provided with any randomized or any treatment driven by the study protocol. If it is clinically applicable, the treatment physician shall make the treatment decision and choose the treatment plan at his discretion.

Study Timeline

• Study Start: 2022-11-20
• Status Verified: 2022-12
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09
• Primary Completion: 2025-11-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patients with hepatitis B: patients who meet the WS299-2008 Diagnostic Standards for Hepatitis B issued by the Ministry of Health.
2. Patients with fatty liver: patients whose liver imaging findings meet the imaging diagnostic criteria for diffuse fatty liver disease or whose liver biopsy histology changes meet the pathological diagnostic criteria for fatty liver disease.
3. Patients with liver cirrhosis: patients who meet the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis (2019) issued by the Hepatology Branch of the Chinese Medical Association;
4. Liver cancer patients: patients who comply with the Diagnostic and Treatment Standards for Primary Liver Cancer (2019 Edition) issued by the National Health Commission of the People's Republic of China.

Exclusion Criteria

• 1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes); 2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ; 3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease; 4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose>1.5 × Upper limit of normal value), mental illness and severe allergic history.

5. BMI is less than 18 or more than 25.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver Cancer patients	Proteomics technology and liquid biopsy	Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (Version 2019) of the Chinese Medical Association
healthy people	Proteomics technology and liquid biopsy	Healthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism
Hepatitis patients	Proteomics technology and liquid biopsy	Patients who meet the diagnostic criteria for hepatitis B (ws 299-2008) and are diagnosed as hepatitis B;
Liver Cirrhosis patients	Proteomics technology and liquid biopsy	Patients who meet the diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis (2019) issued by the Hepatology Branch of the Chinese Medical Association
Fatty Liver patients	Proteomics technology and liquid biopsy	Patients whose liver imaging findings meet the imaging diagnostic criteria for diffuse fatty liver disease or whose liver biopsy histology changes meet the pathological diagnostic criteria for fatty liver disease

Primary Outcome Measures

Name	Time	Method
Achieve the expected number of enrolled cases	3 years	1. Retrospective cohort: 600 patients were recruited, including 120 patients with hepatitis, 120 patients with cirrhosis, 120 patients with fatty liver, 120 patients with liver cancer, and 120 healthy people.; 2. Prospective cohort: 1400 patients were recruited, including 280 hepatitis patients, 280 cirrhosis patients, 280 fatty liver patients, 280 liver cancer patients, and 280 healthy people.

Trial Locations

Locations (1)

Southern medical university; 🇨🇳 Guangzhou, Guangdong, China