Hepatocellular Cancer (HCC) Screening in Zhongshan City

Active, not recruiting

• Conditions: Liver Neoplasms
• Interventions: Biological: Biomarker testing and Ultrasonography

• Registration Number: NCT02501980
• Lead Sponsor: Zhongshan People's Hospital, Guangdong, China

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening	Biomarker testing and Ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
5-year HCC specific mortality rate	10 years	To reduce 5-year HCC specific mortality rate compare with that of general population

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan People's Hospital; 🇨🇳 Zhongshan, Guangdong, China