A Cohort Study (Risk Prediction of HCC in Patients With Chronic Liver Disease)

NCT07820644 | Recruiting DMC

• 1 other identifier: KY2026-057
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the effectiveness of standardized HCC risk stratification management in improving early diagnosis rates in patients with chronic liver disease

Conditions

Liver Cancer (Primary and Metastatic)

Outcome Measures

Primary Outcomes (1)

• Early diagnosis rate of hepatocellular carcinoma (HCC)

  The proportion of participants diagnosed with HCC at an early stage from project initiation until completion of follow-up, defined as the percentage of patients with CNLC stages Ia, Ib, and IIa among all participants with HCC detected in this study.

  Through study completion, an average of 3 years

Secondary Outcomes (1)

• Proportion of participants with regular follow-up

  Through study completion, an average of 3 years

Other Outcomes (1)

• Liver cancer risk-stratified exploratory analyses

  every 12 months, up to 3 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-arm, observational cohort study. The target liver disease patients include those with chronic hepatitis B virus infection, hepatitis C virus infection, liver cirrhosis, metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index of F3 or above, alcoholic liver disease, MAFLD with abnormal glucose metabolism, and those with a first-degree family history of hepatocellular carcinoma. Based on the number of such patients at Shenzhen Third People's Hospital within one case year, this study plans to enroll 15,000 subjects.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Cai Qingxian: lead

Study Sites (1)

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 518000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples will be collected from subjects for liver function tests and routine blood tests from the start of the study to within the first month.

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dongmei Gou, Dr

CONTACT

+8613696020717; gdm4726@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Department of Hepatology

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: September 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)