Hepatocellular Cancer (HCC) Screening in Zhongshan City

Sponsor

Zhongshan People's Hospital, Guangdong, China (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02501980

Collaborator

(none)

20,000

Enrollment

Location

143

Duration (Months)

139.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasms	Biological: Biomarker testing and Ultrasonography

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: Biomarker testing and Ultrasonography
Non-screening All subjects in this arm will be followed by linkage to Cancer Register and Population Register.

Arm

Intervention/Treatment

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.

Biological: Biomarker testing and Ultrasonography

Non-screening

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan People's Hospital	Zhongshan	Guangdong	China	528403

Sponsors and Collaborators

Zhongshan People's Hospital, Guangdong, China

Investigators

Principal Investigator: Mingfang Ji, MD, Zhongshan People's Hospital, Guangdong, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mingfang Ji, Dr. Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

ClinicalTrials.gov Identifier:

NCT02501980

Other Study ID Numbers:

HCC-PRO-001

First Posted:

Jul 17, 2015

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Keywords provided by Mingfang Ji, Dr. Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

Screening

Hepatocellular Cancer

Biomarker

Mortality rate

Additional relevant MeSH terms:

Liver Neoplasms

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Apr 26, 2022