Hepatocellular Cancer (HCC) Screening in Zhongshan City
NCT ID: NCT02501980
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20000 participants
OBSERVATIONAL
2012-01-31
2024-12-31
Brief Summary
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All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening
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.
Biomarker testing and Ultrasonography
Non-screening
All subjects in this arm will be followed by linkage to Cancer Register and Population Register.
No interventions assigned to this group
Interventions
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Biomarker testing and Ultrasonography
Eligibility Criteria
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Inclusion Criteria
* 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 medical records of hepatocellular cancer
35 Years
64 Years
ALL
Yes
Sponsors
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Zhongshan People's Hospital, Guangdong, China
OTHER
Responsible Party
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Mingfang Ji
Dr. Mingfang Ji
Principal Investigators
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Mingfang Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan People's Hospital, Guangdong, China
Locations
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Zhongshan People's Hospital
Zhongshan, Guangdong, China
Countries
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Other Identifiers
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HCC-PRO-001
Identifier Type: -
Identifier Source: org_study_id
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