Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02501980
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-13
First Post:
2015-06-11
Brief Title:
Hepatocellular Cancer HCC Screening in Zhongshan City
Sponsor:
Zhongshan Peoples Hospital Guangdong China
Organization:
Zhongshan Peoples Hospital Guangdong China
Study Overview
Official Title:
Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer HCC in Zhongshan City
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCC
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 andor 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
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 70000 to 120000 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-FetoproteinAFP 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 andor biopsy result
The rest of the blood samples will be stored at the biobank of Zhongshan Peoples 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
Select communities of 70000 to 120000 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-FetoproteinAFP 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 andor biopsy result
The rest of the blood samples will be stored at the biobank of Zhongshan Peoples 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None