Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Hepatitis C, Chronic; Hepatitis B, Chronic; Cirrhosis, Liver; Carcinoma, Hepatocellular; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Liver cancer surveillance annually; Behavioral: Liver cancer surveillance every 6 months; Behavioral: Liver cancer surveillance every 3 months

Study type: Observational

Funder types: Other

Identifiers

NCT05870969

dSEARCH

Details and patient eligibility

About

The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary participation in the clinical study; fully informed about the study and signed informed consent, willing to follow and capable of completing all trial procedures[17]

2. Age: 18 to 75 years old (including the cut-offs)

3. Subjects must meet at least one of the following criteria for enrollment.

   1. Patients diagnosed with chronic hepatitis B in hospital or out of hospital: persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more

   2. Patients diagnosed with hepatitis C in hospital or out of hospital

   3. Patients diagnosed with cirrhosis in hospital or out of hospital who meet 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 when TB was normal and ALT ≤ 40 IU/mL, or LSM ≥ 17.0 kPa when TB was normal and ALT < 200 IU/mL;
      3. Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities and signs of gastroesophageal varices);
      4. APRI ≥ 2.0;
      5. FIB-4 ≥ 3.25

   4. Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 or higher according to transient elastography, i.e., FibroScan® Liver Stiffness Measurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurement threshold[18].

      • MAFLD diagnosis requires diagnosis of >5% fat accumulation in liver through either FibroScan® CAP measurements, or similar parameter, or liver biopsy, and in combination with one of the following three conditions: overweight/obesity (BMI >23 kg/m2), type 2 diabetes, or metabolic dysfunction.

   5. Patients diagnosed with MAFLD combined with abnormal glucose metabolism[19]

      • Abnormal glucose metabolism is defined as type 2 diabetes, or prediabetes, i.e. fasting blood glucose 5.6-6.9 mmol/L, or 2h postprandial blood glucose 7.8-11.0 mmol/L, or glycated hemoglobin 5.7%-6.4%

   6. Subjects with a family history of liver cancer in their first-degree biological relatives.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from the study:

1. Age <18 years or >75 years
2. Patients who have been diagnosed with liver cancer before enrollment
3. Patients with severe mental illness or cognitive impairment
4. Patients who are pregnant or lactating, or preparing to become pregnant
5. Patients who have participated in other clinical trials or are participating in other clinical trials within 3 months prior to initiation of study treatment
6. According to the doctor's judgment, the possibility of the subject being included is low (including inability to understand the project requirements , poor compliance, infirmity, inability to ensure that the protocol can be implemented as required, etc.), or the doctor determines that the subject has any other factors that are not suitable for this study

Trial design

20,000 participants in 4 patient groups

Patients with very high risk for HCC according local guideline

Treatment:

Behavioral: Liver cancer surveillance every 3 months

Patients with high risk for HCC according local guideline

Treatment:

Behavioral: Liver cancer surveillance every 3 months

Patients with medium risk for HCC according local guideline

Treatment:

Behavioral: Liver cancer surveillance every 6 months

Patients with low risk for HCC according local guideline

Treatment:

Behavioral: Liver cancer surveillance annually