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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870969
• Other study ID #: dSEARCH
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 2028

Study information

• Verified date: May 2023
• Source: Ruijin Hospital
• Contact: Qing Xie, MD
• Phone: 0086-021-64370045
• Email: xieqingrjh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis, Liver
• Fatty Liver
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Liver Cirrhosis
• Liver Diseases
• Liver Neoplasms
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Liver cancer surveillance every 3 months
Follow up every 3 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
• Liver cancer surveillance every 6 months
Follow up every 6 months for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
• Liver cancer surveillance annually
Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam

Locations

Country	Name	City	State
China	Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of patients first diagnosed with liver cancer and the annual incidence rate		Four years collectively after the study started
Other	The number of patients first diagnosed with liver cancer and the annual incidence rate within each risk category		Four years collectively after the study started
Other	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		Four years collectively after the study started
Other	The 3-year cumulative incidence of liver cancer in each disease subgroup	The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD	Follow up up to 3 years
Other	Early diagnosis rate of HCC in each disease subgroup	The disease types include but are not limited to hepatitis B, hepatitis C, cirrhosis, MAFLD; early diagnosis of HCC is defined as the patient with stage CNLC Ia, Ib and IIa	Four years collectively after the study started
Other	The compliance rate of each risk group defined at the initial risk stratification	The compliance rates for subjects with very high-risk, high-risk, medium-risk, and low-risk; the compliance rate is defined the same as above	Four years collectively after the study started
Primary	Early diagnosis rate of HCC patients	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.	Follow up up to three years for HCC occurance.
Secondary	Proportion of subjects with regular follow-up	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 ? Theoretical visit interval: theoretical visit date (the date that physician advise to return to hospital for visit) - previous visit date ? Follow-up compliance = (?-?)/? ? 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.	Four years collectively after the study started
Secondary	The distribution of risk stratification of liver cancer in subjects at initial screening	The proportion of very high-risk, high-risk, medium-risk, and low-risk subjects to the whole subject population	Initial screening after enrollment
Secondary	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	The proportion of very high-risk, high-risk, medium-risk and low-risk subjects to the whole subject population	Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up
Secondary	Pooled 3-year cumulative incidence of liver cancer		Follow up up to 3 years
Secondary	The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening	The early diagnosis rate of liver cancer of subjects with very high-risk, high-risk, medium-risk, and low-risk at initial screening, respectively	Initial screening after enrollment
Secondary	The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis	The 3-year cumulative incidence of liver cancer for subjects with very high-risk, high-risk, medium-risk, and low-risk, respectively	Four years collectively after the study started