Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)
NCT ID: NCT05870969
Last Updated: 2023-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2023-03-01
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with very high risk for HCC according local guideline
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
Patients with high risk for HCC according local guideline
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
Patients with medium risk for HCC according local guideline
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
Patients with low risk for HCC according local guideline
Liver cancer surveillance annually
Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Qing XIe
Director of Department of Infectious Diseases, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Locations
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Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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dSEARCH
Identifier Type: -
Identifier Source: org_study_id
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