Risk-stratified approach to catching liver cancer earlier in people with chronic liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, observational cohort study in Shenzhen that follows adults with chronic liver disease to see if a risk-stratified approach improves early liver cancer detection. After enrollment, participants undergo initial liver cancer screening, diagnostic workups if screening is abnormal, and staging using the CNLC system if cancer is found. Those without cancer or with a negative screen are grouped into very high, high, moderate, or low risk and receive corresponding follow-up surveillance for up to three years. The study emphasizes long-term follow-up and sample retention for observing outcomes related to HCC risk stratification and surveillance. Interventions beyond standard screening and follow-up are not specified in this description.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily participate in the clinical study, fully understand and be informed of this study, sign the informed consent form, be willing to comply with and have the ability to complete all trial procedures.
* Age between 18 and 75 years (inclusive)
* Enrolled subjects must meet at least one of the following conditions: \[1\] Diagnosed with chronic hepatitis B virus infection via in-hospital or out-of-hospital pathways: Hepatitis B surface antigen (HBsAg) positive for 6 months or more; \[2\] Diagnosed with chronic hepatitis C virus infection via in-hospital or out-of-hospital pathways; \[3\] Subjects with a first-degree family history of hepatocellular carcinoma (first-degree relatives: parents, children, and full siblings);\[4\]Diagnosed with liver cirrhosis via in-hospital or out-of-hospital pathways, and meeting at least one of the following criteria: a) Liver biopsy showing cirrhosis (Ishak score ≥ 5 or Metavir score = 4); b) Liver Stiffness Measurement (LSM) assessed by FibroScan ® (Echosens™, Paris, France) ≥ 12.0 kPa with normal total bilirubin (TB) and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa with normal TB and ALT \< 200 IU/mL; c) Abdominal imaging findings indicative of cirrhosis (i.e., liver with a coarse texture or with echoes or showing nodularity, parenchymal or morphological abnormalities, and signs of gastroesophageal varices); d) APRI score ≥ 2.0; e) FIB-4 index ≥ 3.25; \[5\] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) via in-hospital or out-of-hospital pathways and with moderate liver fibrosis, specifically defined as a liver fibrosis score of F3 or above based on transient elastography, i.e., FibroScan® LSM ≥ 10 kPa or the corresponding threshold for FibroTouch® \[24\]; or non-invasive liver fibrosis index FIB-4 \> 3.25; or NFS \> 0.67; or APRI \> 1. • The diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) requires evidence of \>5% hepatic steatosis based on the Controlled Attenuation Parameter (CAP) from transient elastography, or similar parameters, or liver biopsy, concurrently with at least one of the following three conditions: overweight/obesity (BMI \> 23 kg/m²), type 2 diabetes, or evidence of metabolic dysregulation. \[6\] Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) complicated by glucose metabolism abnormalities via in-hospital or out-of-hospital pathways: a) Glucose metabolism abnormality is defined as type 2 diabetes, or prediabetes indicated by fasting plasma glucose 5.6-6.9 mmol/L, or 2-hour postprandial glucose 7.8-11.0 mmol/L, or glycated hemoglobin (HbA1c) 5.7%-6.4%

Exclusion Criteria:

* Age \< 18 years or \> 75 years
* Suffering from severe mental illness or cognitive impairment
* Pregnant or breastfeeding patients, or patients planning to become pregnant
* Individuals who have participated in another clinical trial within the last 3 months or are currently participating in another clinical trial
* Individuals deemed by the physician to have a low likelihood of enrollment (including inability to understand project requirements, poor compliance, frailty, inability to ensure the protocol can be followed as required, etc.), or those whom the physician considers to have other factors making them unsuitable for this trial

Where it's running

• The Third People's Hospital of Shenzhen
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Dongmei Gou, Dr
• Email: gdm4726@163.com
• Phone: +8613696020717

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.