Clinical trial NCT02501980: Hepatocellular Cancer (HCC) Screening in Zhongshan City
Official title: Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer (HCC) in Zhongshan City
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Neoplasms
Keywords: Screening
Hepatocellular Cancer
Biomarker
Mortality rate
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 20000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy residences in Zhongshan City.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 5-year HCC specific mortality rate
timeFrame: 10 years
Secondary outcomes:
measure: Early diagnosis rate of HCC
timeFrame: 5 years
measure: Identification of early diagnosis markers of HCC
timeFrame: 5 years
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Mingfang Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: