Hepatocellular Cancer (HCC) Screening in Zhongshan City

Zhongshan City People's Hospital

Status: Active, not recruiting

Conditions: Liver Neoplasms

Treatments: Biological: Biomarker testing and Ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT02501980

HCC-PRO-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20,000 participants in 2 patient groups

Screening

Description:

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.

Treatment:

Biological: Biomarker testing and Ultrasonography

Non-screening

Description:

All subjects in this arm will be followed by linkage to Cancer Register and Population Register.