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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое Liver cancer surveillance annually
  Follow up annually for liver cancer surveillance, including but not limited to serum AFP test and ultrasound exam

Первичные конечные точки

• Early diagnosis rate of HCC patients [Срок оценки: Follow up up to three years for HCC occurance.]

Вторичные конечные точки (6)

• Proportion of subjects with regular follow-up [Срок оценки: Four years collectively after the study started]
• The distribution of risk stratification of liver cancer in subjects at initial screening [Срок оценки: Initial screening after enrollment]
• 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 [Срок оценки: Last follow-up visit or at the time of diagnosis of liver cancer up to three years of follow-up]
• Pooled 3-year cumulative incidence of liver cancer [Срок оценки: Follow up up to 3 years]
• The early diagnosis rate of liver cancer in each subject category according to the risk stratification at initial screening [Срок оценки: Initial screening after enrollment]
• The 3-year cumulative incidence of liver cancer in each subject category according to the risk stratification at the time of initial diagnosis [Срок оценки: Four years collectively after the study started]

Критерии участия

Критерии включения

• 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\[17\]
• 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 at least 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 kPa when TB was normal and ALT < 200 IU/mL;
• Abdominal imaging results showing characteristic of cirrhosis (results showing coarse liver echotexture or nodular, parenchymal, or morphological abnormalities 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 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.
• 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 biological relatives.

Критерии исключения

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 other clinical trials within 3 months prior to initiation of study treatment
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School — Шанхай

Идентификаторы

NCT: NCT05870969 · dSEARCH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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