Liver Neoplasms
Conditions
Keywords
Screening, Hepatocellular Cancer, Biomarker, Mortality rate
Brief summary
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
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.
Interventions
BIOLOGICALBiomarker testing and Ultrasonography
Sponsors
Zhongshan People's Hospital, Guangdong, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year HCC specific mortality rate | 10 years | To reduce 5-year HCC specific mortality rate compare with that of general population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early diagnosis rate of HCC | 5 years | To improve early diagnosis rate of HCC compare with that of general population |
| Identification of early diagnosis markers of HCC | 5 years | To identify early expression markers of HCC |
Countries
China
Outcome results
None listed