Hepatocellular Cancer (HCC) Screening in Zhongshan City (HCC)

July 12, 2023 updated by: Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy residences in Zhongshan City.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year HCC specific mortality rate
Time Frame: 10 years
To reduce 5-year HCC specific mortality rate compare with that of general population
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early diagnosis rate of HCC
Time Frame: 5 years
To improve early diagnosis rate of HCC compare with that of general population
5 years
Identification of early diagnosis markers of HCC
Time Frame: 5 years
To identify early expression markers of HCC
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan People's Hospital, Guangdong, China

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimated)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-PRO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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