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Trial Title:
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Liver Cancer
NCT ID:
NCT05719480
Condition:
Liver Cancer
Liver Cirrhosis
Fatty Liver
Hepatitis
Conditions: Official terms:
Liver Neoplasms
Fatty Liver
Liver Cirrhosis
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Proteomics technology and liquid biopsy
Description:
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
Arm group label:
Fatty Liver patients
Arm group label:
Hepatitis patients
Arm group label:
Liver Cancer patients
Arm group label:
Liver Cirrhosis patients
Arm group label:
healthy people
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Start date:
November 20, 2022
Completion date:
December 20, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05719480
