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

Recruiting

• Conditions: Carcinoma, Hepatocellular; Hepatitis B, Chronic; Hepatitis C, Chronic; Cirrhosis, Liver; Non-Alcoholic Fatty Liver Disease
• Interventions: Behavioral: Liver cancer surveillance every 6 months; Behavioral: Liver cancer surveillance every 3 months; Behavioral: Liver cancer surveillance annually

• Registration Number: NCT05870969
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-13
• Study First Submitted QC: 2023-05-13
• Last Update Submitted: 2023-05-13
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with medium risk for HCC according local guideline	Liver cancer surveillance every 6 months	-
Patients with very high risk for HCC according local guideline	Liver cancer surveillance every 3 months	-
Patients with high risk for HCC according local guideline	Liver cancer surveillance every 3 months	-
Patients with low risk for HCC according local guideline	Liver cancer surveillance annually	-

Primary Outcome Measures

Name	Time	Method
Early diagnosis rate of HCC patients	Follow up up to three years for HCC occurance.	The proportion of patients who are first diagnosed with HCC at early stage to all the patients diagnosed as liver cancer in the study, from the start of the study to the completion of follow-up. Early diagnosis is defined as the patient with stage CNLC Ia, Ib and IIa.

Secondary Outcome Measures

Name	Time	Method
The distribution of risk stratification of liver cancer in subjects at the last follow-up visit or at the time of diagnosis of liver cancer	Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up	The proportion of very high-risk, high-risk, medium-risk and low-risk subjects to the whole subject population
Pooled 3-year cumulative incidence of liver cancer	Follow up up to 3 years
The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening	Initial screening after enrollment	The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively
The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis	Four years collectively after the study started	The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively
The distribution of risk stratification of liver cancer in subjects at initial screening	Initial screening after enrollment	The proportion of very high-risk, high-risk, medium-risk, and low-risk subjects to the whole subject population
Proportion of subjects with regular follow-up	Four years collectively after the study started	Regular follow-up is defined as the average difference between the actual treatment time and the theoretical treatment time equal or less than 1/3; * Actual visit interval: actual visit date - previous visit date ② Theoretical visit interval: theoretical visit date (the date that physician advise to return to hospital for visit) - previous visit date ③ Follow-up compliance = (②-①)/② ④ Patient with regular follow-up is defined as the patient whose mean follow-up compliance is equal to, or less than 1/3; * The compliance of the study is defined as the proportion of subjects with regular follow-up to all subjects in the study.

Trial Locations

Locations (1)

Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China