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

February 8, 2023 updated by: Nanfang Hospital of Southern Medical University

A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Liver Cancer in Southern China

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieve the expected number of enrolled cases
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2022

Primary Completion (ANTICIPATED)

November 20, 2025

Study Completion (ANTICIPATED)

December 20, 2025

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-441

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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