Hepatocellular Cancer (HCC) Screening in Zhongshan City | NCT02501980

Studies
Hepatocellular Cancer (HCC) Screening in Zhongshan City

NCT02501980

Sponsor

Zhongshan People's Hospital, Guangdong, China

Status

Unknown status

Last Update Posted

Jul 13, 2023Actual

Enrollment

20,000Actual

Phase

Not provided

Conditions

Liver Neoplasms

Interventions

Biomarker testing and Ultrasonography

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jun 11, 2015

First Submission Date that Met QC Criteria

Jul 16, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2023

Last Update Posted Date

Jul 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mingfang Ji, Dr. Mingfang Ji, Zhongshan People's Hospital, Guangdong, ChinaPrincipal Investigator

Lead Sponsor

Zhongshan People's Hospital, Guangdong, ChinaOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biomarker testing and Ultrasonography	Biological		Screening

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Healthy residences in Zhongshan City.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mingfang Ji, MD	Zhongshan People's Hospital, Guangdong, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan People's Hospital		Zhongshan	Guangdong	528403	China

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided