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

NCT05719480 | Unknown

• 1 other identifier: NFEC-2022-441
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Liver Cirrhosis; Fatty Liver; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Achieve the expected number of enrolled cases

  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.

  3 years

Study Arms (5)

Liver Cancer patients

Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (Version 2019) of the Chinese Medical Association

Diagnostic Test: Proteomics technology and liquid biopsy

Liver Cirrhosis patients

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

Diagnostic Test: Proteomics technology and liquid biopsy

Fatty Liver patients

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

Diagnostic Test: Proteomics technology and liquid biopsy

Hepatitis patients

Patients who meet the diagnostic criteria for hepatitis B (ws 299-2008) and are diagnosed as hepatitis B;

Diagnostic Test: Proteomics technology and liquid biopsy

healthy people

Healthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism

Diagnostic Test: Proteomics technology and liquid biopsy

Interventions

Proteomics technology and liquid biopsy DIAGNOSTIC_TEST

using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites in different liver diseases during the development of liver cancer by collecting residual blood and urine from routine diagnosis and treatment or physical examination

Fatty Liver patients; Hepatitis patients; Liver Cancer patients; Liver Cirrhosis patients; healthy people

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who met the diagnosis and criteria of hepatitis B,fatty live,liver cirrhosis or Liver cancer and were hospitalized in Southern Hospital of Southern Medical University.Subjects agreed to participate in the study and signed the informed consent form.

You may qualify if:

• Patients with hepatitis B: patients who meet the WS299-2008 Diagnostic Standards for Hepatitis B issued by the Ministry of Health.
• 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.
• 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;
• 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.

You may not qualify if:

• \- 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.
• \. BMI is less than 18 or more than 25.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Urine

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis; Fatty Liver; Hepatitis

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• jian guan, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jian guan, MD

CONTACT

136 3210 2247; guanjian5461@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 9, 2023
• Study Start: November 20, 2022
• Primary Completion: November 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 9, 2023

Record last verified: 2022-12

Locations

CN (1)