Hepatocellular Cancer (HCC) Screening in Zhongshan City

Study Overview
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Brief Summary
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All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Detailed Description
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Sample selection Select communities of 70,000 to 120,000 populations in Zhongshan City as the investigators' fields. Divide them into screening group and control group according to the areas of administration Participants recruitment - Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires - Face-to-face interviews are conducted by well-trained investigators Serological tests Each blood samples will be tested for the surface antigen of the hepatitis B virus (HBsAg). Among those who are positive for HBsAg, further clinical work-ups including Alpha-Fetoprotein(AFP) test and ultrasonography for liver exam will be performed and high risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital. Follow up The cohort will follow up according to the screening protocol. Briefly, Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Official Title
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Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer (HCC) in Zhongshan City

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Biological: Biomarker testing and Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residences in Zhongshan City Have no medical records of hepatocellular cancer ECOG 0-2 Provide written informed consent forms Have a good physical and psychological condition Exclusion Criteria: Have severe cardiovascular or kidney disease Have medical records of hepatocellular cancer

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening<br>All participants will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. | Biological: Biomarker testing and Ultrasonography<br> <br> |
| Non-screening<br>All subjects in this arm will be followed by linkage to Cancer Register and Population Register. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year HCC specific mortality rate | To reduce 5-year HCC specific mortality rate compare with that of general population | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early diagnosis rate of HCC | To improve early diagnosis rate of HCC compare with that of general population | 5 years | 
| Identification of early diagnosis markers of HCC | To identify early expression markers of HCC | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Hepatocellular Cancer, Biomarker, Mortality rate