Hepatocellular Cancer (HCC) Screening in Zhongshan City

NCT ID: NCT02501980

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Liver Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biomarker testing and Ultrasonography

Intervention Type BIOLOGICAL

Non-screening

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

No interventions assigned to this group

Interventions

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Biomarker testing and Ultrasonography

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role lead

Responsible Party

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Mingfang Ji

Dr. Mingfang Ji

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingfang Ji, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan People's Hospital, Guangdong, China

Locations

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Zhongshan People's Hospital

Zhongshan, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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HCC-PRO-001

Identifier Type: -

Identifier Source: org_study_id

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