Hepatocellular Cancer (HCC) Screening in Zhongshan City

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02501980
Study type	Observational [Patient Registry]
Source	Zhongshan People's Hospital, Guangdong, China
Contact
Status	Active, not recruiting
Phase
Start date	January 2012
Completion date	December 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hepatocellular Cancer (HCC) Screening in Zhongshan City — HCC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms