Hepatitis B
Conditions
Interventions
Liver disease group (chronic hepatitis B):None
Liver disease group (cirrhosis):None
Liver Disease Group (Liver Cancer):None
Health group:None
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for the liver disease cohort (including chronic hepatitis B without cirrhosis, HBV-related cirrhosis, and HBV-related hepatocellular carcinoma cohorts): (1) Age requirement: male or female, aged 18 years or older; (2) Informed consent: all participants must sign a written informed consent form; (3) Evidence of chronic HBV infection for at least 6 months prior to screening; (4) Patients with liver cancer and cirrhosis must meet the corresponding diagnostic criteria; 2. Inclusion criteria for the healthy cohort: (1) Health status: participants have no abnormal liver imaging findings or other abnormalities; (2) Age requirement: male or female, aged 18 years or older; (3) Informed consent: all participants must sign a written informed consent form; (4) Physical condition: must be in good health, no specific physical fitness score required; (5) Organ function: no obvious organ dysfunction or disease.
Exclusion criteria
Exclusion criteria: 1. In addition to a history of chronic HBV infection, patients with other clinically significant liver diseases (such as hepatitis C virus, hepatitis D virus, human immunodeficiency virus or other liver virus positivity; autoimmune liver disease; alcoholic liver disease; nonalcoholic fatty liver disease, etc.); 2. Pregnant or breastfeeding women: women who are currently pregnant or breastfeeding are not eligible for this study; 3. History of tumors: individuals who have had tumors other than liver cancer do not meet the inclusion criteria for this study; 4. Recent liver surgery or interventional treatment: patients who have undergone liver surgery or interventional treatment within the past month will be excluded; 5. Acute decompensation symptoms: patients presenting with acute decompensation symptoms such as fever or bleeding are not eligible for this study; 6. Dietary restrictions: individuals who have not met the requirements of at least 10 hours of fasting, 12 hours of abstaining from alcohol, and 4 hours of abstaining from smoking will be excluded. Within 12 hours, consumption of orange juice or citrus foods is prohibited; 7. History of organ transplantation: (1) Individuals who have previously received an organ transplant are not eligible for this study; (2) Individuals who have previously received non-autologous (allogeneic) bone marrow or stem cell transplantation also do not meet the inclusion criteria; 8. Major organic or psychiatric diseases: (1) Individuals with other serious organic diseases will be excluded; (2) Individuals with psychiatric disorders also do not meet the inclusion criteria; 9. Respiratory system diseases: individuals with respiratory diseases will be excluded from this study; 10. Other inappropriate conditions: individuals whom the investigators consider otherwise unsuitable to participate in this clinical trial also do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical diagnostic results, diagnostic capability of exhaled breath VOC molecules: AUC (area under the ROC curve), sensitivity, specificity, predictive accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation coefficients of exhaled VOC molecular metabolic parameters with the severity of liver cirrhosis (Child-Pugh classification, MELD score), portal hypertension (based on the CSPH diagnostic criteria in the Baveno VII consensus on portal hypertension), and liver cancer staging (BCLC staging); | — |
Countries
China
Contacts
Public ContactHou Jinlin
Southern Medical University Southern Hospital
Outcome results
None listed