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

NCT ID: NCT05719480

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2025-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cancer Liver Cirrhosis Fatty Liver Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Proteomics technology and liquid biopsy

Intervention Type 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

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

Proteomics technology and liquid biopsy

Intervention Type 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

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

Proteomics technology and liquid biopsy

Intervention Type 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

Hepatitis patients

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

Proteomics technology and liquid biopsy

Intervention Type 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

healthy people

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

Proteomics technology and liquid biopsy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

jian guan, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southern medical university

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

jian guan, MD

Role: CONTACT

136 3210 2247

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jian Guan, M.D.

Role: primary

86+13632102247

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NFEC-2022-441

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.