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Trial Title:
Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)
NCT ID:
NCT05870969
Condition:
Carcinoma, Hepatocellular
Hepatitis C, Chronic
Hepatitis B, Chronic
Cirrhosis, Liver
Non-Alcoholic Fatty Liver Disease
Conditions: Official terms:
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis C, Chronic
Hepatitis B, Chronic
Liver Neoplasms
Carcinoma, Hepatocellular
Hepatitis
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Liver Extracts
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Liver cancer surveillance every 3 months
Description:
Follow up every 3 months for liver cancer surveillance, including but not limited to
serum AFP test and ultrasound exam
Arm group label:
Patients with high risk for HCC according local guideline
Arm group label:
Patients with very high risk for HCC according local guideline
Intervention type:
Behavioral
Intervention name:
Liver cancer surveillance every 6 months
Description:
Follow up every 6 months for liver cancer surveillance, including but not limited to
serum AFP test and ultrasound exam
Arm group label:
Patients with medium risk for HCC according local guideline
Intervention type:
Behavioral
Intervention name:
Liver cancer surveillance annually
Description:
Follow up annually for liver cancer surveillance, including but not limited to serum AFP
test and ultrasound exam
Arm group label:
Patients with low risk for HCC according local guideline
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing Xie, MD, PhD.
Phone:
0086-021-64370045
Phone ext:
680403
Email:
xieqingrjh@163.com
Contact backup:
Last name:
Honglian Gui, MD,PhD
Phone:
0086-021-64370045
Phone ext:
680419
Email:
lillian_ghl@163.com
Investigator:
Last name:
Qing Xie, MD, PhD.
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
March 2028
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870969
