Population-wide Research for HBV-related Liver Diseases in Maoming City

NCT06184347 | Unknown

• 1 other identifier: NFEC-2023-474
• Study Type: observational
• Target: 3,700,000
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

HBV Infection; Chronic Hepatitis B; Cirrhosis; HCC

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2024.02-2025.08

Secondary Outcomes (3)

• Estimation of the Hepatitis B virus infection rate in Guangdong Province

  2024.02-2025.08

• Early diagnosis rate of liver cirrhosis or hepatocellular carcinoma

  2024.02-2025.08

• The current therapeutic rate of chronic hepatitis B

  2024.02-2025.08

Study Arms (2)

Screening group

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

Control group

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.

Interventions

Rapid tests for HBsAg OTHER

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

Screening group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population in Guangdong Province

You may qualify if:

• Screening Group
• Individuals with all the following characteristics can be included:
• Aged from 20 to 70;
• From the residential population of Maoming City, Guangdong Province;
• Voluntarily participate and provide written informed consent forms.
• Control Group
• Individuals with all the following characteristics can be included:
• Aged from 20 to 70;
• From the residential population of Wuchuan City and Yangchun City, Guangdong Province.

You may not qualify if:

• Screening Group
• Individuals with all the following characteristics should be excluded:
• Floating population and temporary residents;
• Diagnosed with severe mental diseases who are unable to communicate normally;
• Determined by the researchers to be unsuitable for this study;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Related Publications (4)

• Jeng WJ, Papatheodoridis GV, Lok ASF. Hepatitis B. Lancet. 2023 Mar 25;401(10381):1039-1052. doi: 10.1016/S0140-6736(22)01468-4. Epub 2023 Feb 9.

  PMID: 36774930 BACKGROUND

• Liu Z, Lin C, Mao X, Guo C, Suo C, Zhu D, Jiang W, Li Y, Fan J, Song C, Zhang T, Jin L, De Martel C, Clifford GM, Chen X. Changing prevalence of chronic hepatitis B virus infection in China between 1973 and 2021: a systematic literature review and meta-analysis of 3740 studies and 231 million people. Gut. 2023 Nov 24;72(12):2354-2363. doi: 10.1136/gutjnl-2023-330691.

  PMID: 37798085 BACKGROUND

• Su S, Wong WC, Zou Z, Cheng DD, Ong JJ, Chan P, Ji F, Yuen MF, Zhuang G, Seto WK, Zhang L. Cost-effectiveness of universal screening for chronic hepatitis B virus infection in China: an economic evaluation. Lancet Glob Health. 2022 Feb;10(2):e278-e287. doi: 10.1016/S2214-109X(21)00517-9.

  PMID: 35063115 BACKGROUND

• Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023 Aug;20(8):524-537. doi: 10.1038/s41575-023-00760-9. Epub 2023 Apr 6.

  PMID: 37024566 BACKGROUND

Related Links

• HBV progress towards coverage targets

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Hepatitis B, Chronic; Fibrosis

Interventions

Hepatitis B Surface Antigens

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Li Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Liu

CONTACT

+86 18602062738; liuli@i.smu.edu.cn

Chang Hong

CONTACT

+86 13750416661; shanoicy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 28, 2023
• Study Start: February 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01