NCT07820644Recruiting
A Cohort Study (Risk Prediction of HCC in Patients With Chronic Liver Disease)
A Single-center, Open-label, Single-arm, Observational Cohort Study on Early Diagnosis and Risk Prediction of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Based on a Digital Management Platform
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15000 (estimated)
- First submitted
- 10 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Cai Qingxian
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07820644
What you commit to
- Study type: Observational
- Planned participants: 15000
- From 1 Jun 2026 to the primary completion date, 31 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Suffering from severe mental illness or cognitive impairment
Age
- Age \< 18 years or \> 75 years
Other
- 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
Who the study is looking for
- 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%
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third People's Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.