Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184347
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-13
Brief Title:
Population-wide Research for HBV-related Liver Diseases in Maoming City
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
A Prospective and Observational Investigation on Chronic Hepatitis B Virus Infection and Related Liver Diseases Via Systematic Screening in General Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
PreMAO
Brief Summary:
Hepatitis B virus HBV infection is a major public health problem and chronic HBV infection affects about 296 million people worldwide and is the leading etiology of cirrhosis and hepatocellular carcinoma globally China takes up a great deal of the responsibility towards the goal of eliminating viral hepatitis by 2030 released by the World Health Organization WHO as China has the worlds largest burden of HBV infection The current diagnostic rate barely reaches 24 which is significantly short of the target diagnostic rate of 90 proposed by WHO Progression from chronic hepatitis B CHB to hepatic complications-fibrosis cirrhosis and HCC-can be prevented significantly by preemptive antiviral therapy However the onset of CHB seldom manifests with typical symptoms and most cases at their first diagnosis have progressed to end-stage liver diseases Therefore early detection of CHB and its complications that not only raises public awareness of preventing infection but also brings the patients into the management system is urgent blocking the progression to cirrhosis and HCC
The study is a prospective and observational study involving community-based screening of chronic HBV infection and related liver diseases systematically among the general population of Guangdong Province China Individuals in Maoming City aged 20-70 years will be enrolled in the screening group for the HBsAg screening using a finger blood test Positive participants will receive further examinations including laboratory and imaging examinations to discover HBV-related liver diseases The control group will be enrolled from the general population in two similar cities
By thoroughly investigating the epidemiological landscape and antiviral situation of chronic hepatitis B through population screening this study intends to furnish the administration with updated epidemiological data Additionally the project seeks to establish a CHB screening cohort to enhance early diagnosis and treatment rates for both HBV-related liver diseases Collectively the study aspires to improve the overall prognosis for patients with chronic HBV infection reduce CHB-related mortality and ultimately put forward valuable healthcare insights and evidence-based medicine EBM practices for the effective implementation of CHB screening and management
The study is a prospective and observational study involving community-based screening of chronic HBV infection and related liver diseases systematically among the general population of Guangdong Province China Individuals in Maoming City aged 20-70 years will be enrolled in the screening group for the HBsAg screening using a finger blood test Positive participants will receive further examinations including laboratory and imaging examinations to discover HBV-related liver diseases The control group will be enrolled from the general population in two similar cities
By thoroughly investigating the epidemiological landscape and antiviral situation of chronic hepatitis B through population screening this study intends to furnish the administration with updated epidemiological data Additionally the project seeks to establish a CHB screening cohort to enhance early diagnosis and treatment rates for both HBV-related liver diseases Collectively the study aspires to improve the overall prognosis for patients with chronic HBV infection reduce CHB-related mortality and ultimately put forward valuable healthcare insights and evidence-based medicine EBM practices for the effective implementation of CHB screening and management
Detailed Description:
Sample selection Individuals aged from 20-70 years old who permanently reside in Maoming City will be enrolled in the screening group
The natural population from another two cities which share economic climatic and customary similarities with Maoming City will be enrolled in the control group
Participants recruitment Participants who voluntarily attend the screening project will be recruited to the screening group Personal and medical information of the control group will be fetched from the Guangdong Provincial Center for Disease Control and Prevention the Cancer Register the Population Register and other relevant systems
Informed consent Informed consent forms will be collected at the recruitment in the screening group
Questionnaires Questionnaires will be conducted face-to-face by well-trained investigators to gather the personal information of the participants in the screening group and inquire about the previous and current medical history of them and their families concerning viral hepatitis cirrhosis and HCC
HBsAg screening test Participants in the screening group will firstly receive the HBsAg screening using a finger blood test
Laboratory and imaging examinations Participants positive for the HBsAg screening test in the screening group will undergo further clinical examination to determine if their infections have developed CHB and even HCC The laboratory examination includes blood routine tests white blood cell count WBC red blood cell count RBC hemoglobin HGB platelet count PLT liver function total bilirubin TBIL albumin ALB alanine aminotransferase ALT HBV serologic markers alpha-fetoprotein AFP abnormal Prothrombin II PIVKA II and HBV-DNA Patients with HBsAg-positive status undergo liver ultrasound examination If suspicious liver nodules or elevated AFP levels are detected further refinement through abdominal CT or MRI is recommended
The natural population from another two cities which share economic climatic and customary similarities with Maoming City will be enrolled in the control group
Participants recruitment Participants who voluntarily attend the screening project will be recruited to the screening group Personal and medical information of the control group will be fetched from the Guangdong Provincial Center for Disease Control and Prevention the Cancer Register the Population Register and other relevant systems
Informed consent Informed consent forms will be collected at the recruitment in the screening group
Questionnaires Questionnaires will be conducted face-to-face by well-trained investigators to gather the personal information of the participants in the screening group and inquire about the previous and current medical history of them and their families concerning viral hepatitis cirrhosis and HCC
HBsAg screening test Participants in the screening group will firstly receive the HBsAg screening using a finger blood test
Laboratory and imaging examinations Participants positive for the HBsAg screening test in the screening group will undergo further clinical examination to determine if their infections have developed CHB and even HCC The laboratory examination includes blood routine tests white blood cell count WBC red blood cell count RBC hemoglobin HGB platelet count PLT liver function total bilirubin TBIL albumin ALB alanine aminotransferase ALT HBV serologic markers alpha-fetoprotein AFP abnormal Prothrombin II PIVKA II and HBV-DNA Patients with HBsAg-positive status undergo liver ultrasound examination If suspicious liver nodules or elevated AFP levels are detected further refinement through abdominal CT or MRI is recommended
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None