Clinical trial NCT05870969: Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)
Official title: Exploration of A Holistic Management Procedure for Liver Cancer Surveillance in Improving Liver Cancer's Early Diagnosis Efficacy in Chinese Population: Single-Center, Prospective, Observational Real-world Study in EASTERN China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Hepatocellular
Hepatitis C, Chronic
Hepatitis B, Chronic
Cirrhosis, Liver
Non-Alcoholic Fatty Liver Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study mainly includes the following risk groups of liver cancer: patients with chronic hepatitis B, patients with hepatitis C, patients with liver cirrhosis, patients with metabolic dysfunction-associated fatty liver disease (MAFLD) with a liver fibrosis index F3 or above, MAFLD patients combined with abnormal glucose metabolism, and people with a family history of liver cancer in their first-degree biological relatives.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Early diagnosis rate of HCC patients
timeFrame: Follow up up to three years for HCC occurance.
Secondary outcomes:
measure: Proportion of subjects with regular follow-up
timeFrame: Four years collectively after the study started
measure: The distribution of risk stratification of liver cancer in subjects at initial screening
timeFrame: Initial screening after enrollment
measure: 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
timeFrame: Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up
measure: Pooled 3-year cumulative incidence of liver cancer
timeFrame: Follow up up to 3 years
measure: The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening
timeFrame: Initial screening after enrollment
measure: The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis
timeFrame: Four years collectively after the study started
Other outcomes:
measure: The number of patients first diagnosed with liver cancer and the annual incidence rate
timeFrame: Four years collectively after the study started
measure: The number of patients first diagnosed with liver cancer and the annual incidence rate within each risk category
timeFrame: Four years collectively after the study started
measure: The distribution of the CNLC staging of patients diagnosed as liver cancer first from the start of the study to the completion of follow-up
timeFrame: Four years collectively after the study started
measure: The 3-year cumulative incidence of liver cancer in each disease subgroup
timeFrame: Follow up up to 3 years
measure: Early diagnosis rate of HCC in each disease subgroup
timeFrame: Four years collectively after the study started
measure: The compliance rate of each risk group defined at the initial risk stratification
timeFrame: Four years collectively after the study started
Locations:
city: Shanghai
country: China
facility: Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: