An observational study in HBV Infection, Chronic Hepatitis B and Cirrhosis, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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 world's 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.
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 3,700,000 is above the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
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General population in Guangdong Province
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Screening Group
Individuals with all the following characteristics can be included:
Individuals with all the following characteristics can be included:
Exclusion criteria:
Screening Group
Individuals with all the following characteristics should be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive an HBsAg finger blood test and a questionnaire gathering their personal information and medical history concerning viral hepatitis, cirrhosis, and hepatocellular carcinoma. Individuals positive for HBsAg will undergo further clinical detections to distinguish dormant liver diseases and HCC.
Other: Rapid tests for HBsAg
All subjects in this arm will be followed by linkage to the Guangdong Provincial Center for Disease Control and Prevention, Cancer Registry, and Population Registry.
Participants in the screening group will firstly receive the HBsAg screening using a finger blood test. The laboratory examination includes blood routine test (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. The imaging examination includes liver ultrasound, abdominal CT, or MRI. HBsAg-positive participants also undergo liver ultrasound examination. If suspicious liver nodules or elevated AFP levels are detected, further refinement through abdominal CT or MRI is recommended.
Also known as: Laboratory examination of sample of blood, Imaging examination
Estimation of the HBV-related liver disease incidences in Guangdong Province
The incidences of HBV-related liver diseases will be calculated as the percentage of patients diagnosed with Hepatitis B, cirrhosis, and HCC in the screening and control groups, which will be used to estimate the HBV-related liver disease incidences in Guangdong Province.
Time frame: 2024.02-2025.08
Propotion of participants who are eligible for and would benefit from antiviral therapy.
Propotion of participants who are eligible for and would benefit from antiviral therapy will be based on the percentage of patients who need antiviral therapy after being diagnosed with Hepatitis B, cirrhosis, and HCC in the screening group.
Time frame: 2024.02-2025.08
Estimation of the Hepatitis B virus infection rate in Guangdong Province
The Hepatitis B virus infection rate will be based on the percentage of subjects positive for HBV in the screening and control groups, which will be used to estimate the Hepatitis B virus infection rate in Guangdong Province.
Time frame: 2024.02-2025.08
Early diagnosis rate of liver cirrhosis or hepatocellular carcinoma
The early diagnosis rate of liver cirrhosis and hepatocellular carcinoma is based on the percentage of CHB patients who have received a confirmed diagnosis of cirrhosis or HCC by the total number of individuals with CHB in the screening group.
Time frame: 2024.02-2025.08
The current therapeutic rate of chronic hepatitis B
The current therapeutic coverage of chronic hepatitis B will be based on the percentage of patients who accepted antiviral therapy after being diagnosed with HBV infection before screening.
Time frame: 2024.02-2025.08
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University →