Hepatocellular Cancer (HCC) Screening in Zhongshan City

Liver Neoplasms Clinical Trial

— HCC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02501980
• Other study ID #: HCC-PRO-001
• Status: Active, not recruiting
• Start date: January 2012
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Zhongshan People's Hospital, Guangdong, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: December 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Biological:
• Biomarker testing and Ultrasonography

Locations

Country	Name	City	State
China	Zhongshan People's Hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year HCC specific mortality rate	To reduce 5-year HCC specific mortality rate compare with that of general population	10 years
Secondary	Early diagnosis rate of HCC	To improve early diagnosis rate of HCC compare with that of general population	5 years
Secondary	Identification of early diagnosis markers of HCC	To identify early expression markers of HCC	5 years