Improving early diagnosis of liver cancer in high-risk patients in China
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
This study is testing if regular check-ups for liver cancer can help catch the disease earlier in people at high risk due to conditions like chronic hepatitis or cirrhosis in China.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05870969 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of standardized liver cancer risk stratification management in enhancing the early diagnosis rate of liver cancer among high-risk populations in China. Participants will undergo liver cancer surveillance at intervals of every 3 months, 6 months, or annually, depending on their risk factors. The study focuses on individuals diagnosed with chronic hepatitis B, chronic hepatitis C, cirrhosis, and non-alcoholic fatty liver disease. By systematically monitoring these patients, the study seeks to identify liver cancer at an earlier stage, potentially leading to better treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 75 who have been diagnosed with chronic hepatitis B, chronic hepatitis C, cirrhosis, or non-alcoholic fatty liver disease.
Not a fit: Patients who do not have any of the specified liver conditions or are outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the early detection of liver cancer, improving survival rates for patients at high risk.
How similar studies have performed: Other studies have shown that structured surveillance programs can improve early detection rates for liver cancer, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qing Xie, MD
- Email: xieqingrjh@163.com
- Phone: 0086-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.