Last updated: May 13, 2023
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hepatitis
Liver Cancer
Hepatitis B
Treatment
Liver cancer surveillance every 3 months
Liver cancer surveillance every 6 months
Liver cancer surveillance annually
Clinical Study ID
NCT05870969
dSEARCH
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntary participation in the clinical study; fully informed about the study andsigned informed consent, willing to follow and capable of completing all trialprocedures[17]
- Age: 18 to 75 years old (including the cut-offs)
- Subjects must meet at least one of the following criteria for enrollment.
- Patients diagnosed with chronic hepatitis B in hospital or out of hospital:persistent positive hepatitis B surface antigen (HBsAg) for 6 months or more
- Patients diagnosed with hepatitis C in hospital or out of hospital
- Patients diagnosed with cirrhosis in hospital or out of hospital who meet atleast one of the following criteria.
- Liver biopsy showing cirrhosis (Ishak score ≥5 or Metavir score = 4);
- 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 kPawhen TB was normal and ALT < 200 IU/mL;
- Abdominal imaging results showing characteristic of cirrhosis (resultsshowing coarse liver echotexture or nodular, parenchymal, or morphologicalabnormalities and signs of gastroesophageal varices);
- APRI ≥ 2.0;
- FIB-4 ≥ 3.25
- Patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) in hospital or out of hospital who have a liver fibrosis score of F3 orhigher according to transient elastography, i.e., FibroScan® Liver StiffnessMeasurement (LSM) ≥ 10 kPa or the corresponding FibroTouch® measurementthreshold[18].
- MAFLD diagnosis requires diagnosis of >5% fat accumulation in liver througheither 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 metabolicdysfunction.
- 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%
- Subjects with a family history of liver cancer in their first-degree biologicalrelatives.
Exclusion
Exclusion Criteria: Patients meeting any of the following criteria will be excluded from the study:
- Age <18 years or >75 years
- Patients who have been diagnosed with liver cancer before enrollment
- Patients with severe mental illness or cognitive impairment
- Patients who are pregnant or lactating, or preparing to become pregnant
- Patients who have participated in other clinical trials or are participating in otherclinical trials within 3 months prior to initiation of study treatment
- According to the doctor's judgment, the possibility of the subject being included islow (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 notsuitable for this study
Study Design
Total Participants: 20000
Treatment Group(s): 3
Primary Treatment: Liver cancer surveillance every 3 months
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2028
Connect with a study center
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai
ChinaActive - Recruiting
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