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Construction of a chronic liver disease sample bank and liver cancer early screening cohort study in western Guangdong

Construction of a chronic liver disease sample bank and liver cancer early screening cohort study in western Guangdong

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098440
Enrollment
Unknown
Registered
2025-03-07
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with chronic liver disease and high risk of liver cancer who have hepatitis B, hepatitis C, cirrhosis, metabolic-associated fatty liver disease (MAFLD) and moderate liver fibrosis.

Interventions

Case series :none

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with chronic hepatitis B through in-hospital or out-of-hospital channels: Hepatitis B surface antigen continues to be positive for 6 months or more; 2. Patients diagnosed with chronic hepatitis C through in-hospital or out-of-hospital channels; 3. For patients diagnosed with cirrhosis either in-hospital or outpatient, the presence of cirrhosis is indicated by abnormalities in the following test indicators (meeting at least one of the following criteria): (1) Liver biopsy showing cirrhosis (Ishak score >= 5 or Metavir score = 4); (2) Liver stiffness measurement (LSM) using FibroScan ® (Echosens™, Paris, France) >= 12.0 kPa with normal serum total bilirubin (TB) and ALT = 17.0 kPa with normal TB and ALT = 2.0; (5) FIB-4 index >= 3.25. 4. For patients diagnosed with metabolic-associated fatty liver disease (MAFLD) and moderate liver fibrosis, either in-hospital or outpatient, the specific criteria are as follows: a liver fibrosis score of F3 or above according to liver transient elastography, which corresponds to a liver stiffness measurement (LSM) value of =10 kPa using FibroScan® or the corresponding threshold for FibroTouch® [24]; or a non-invasive liver fibrosis index of FIB-4 > 3.25; or NFS > 0.67; or APRI > 1. (1) Metabolic-associated fatty liver disease is defined by controlled attenuation parameter (CAP) from transient elastography, or similar parameters, or liver biopsy diagnosing >5% fat accumulation, accompanied by one of the following three conditions: overweight/obesity (BMI > 23 kg/m²), type 2 diabetes, or metabolic dysfunction. 5. For patients diagnosed with metabolic-associated fatty liver disease (MAFLD) complicated with abnormal glucose metabolism through inpatient or outpatient services: (1) The definition of metabolic-associated fatty liver disease is the same as in d) (2) Abnormal glucose metabolism is defined as type 2 diabetes or prediabetes, which is indicated by a fasting plasma glucose level of 5.6-6.9 mmol/L, or a 2-hour postprandial plasma glucose level of 7.8-11.0 mmol/L, or a glycated hemoglobin level of 5.7%-6.4%. 6. Subjects with a family history of liver cancer in first-degree relatives (first-degree relatives: parents, children, siblings);

Exclusion criteria

Exclusion criteria: 1. Age 75 years old; 2. Those with severe mental illness or cognitive impairment; 3. According to the doctor’s judgment, the possibility of selection is low (including inability to understand project requirements, poor compliance, frailty, and inability to Ensure that the plan can be implemented as required, etc.), or the doctor believes that there are other factors that are not suitable for this project.

Design outcomes

Primary

MeasureTime frame
Liver cancer screening;

Countries

China

Contacts

Public ContactLiu Bin

Affiliated Hospital of Guangdong Medical University

binliu831201@163.com+86 759 2369036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026