The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection

NCT07240350 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2021-01-01

Last updated

2026-04-16

Condition(s) studied

Hepatitis B Virus Infection

Investigational drug(s) / intervention(s)

Tissue resection

Tissue resection: The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery and the group of HBV-negative patients who underwent liver, spleen, tonsil, and lymph node surgery

Study summary

The purpose of this observational study is to investigate the structure and composition of germinal centers in individuals with chronic HBV infection. The primary questions it aims to address are:

What are the phenotypes, functions, and complexity of B cell clones of the immune cells within the germinal centers of chronic HBV-infected individuals? Do chronic HBV-infected individuals have ectopic germinal centers in the liver? This will be studied by collecting peripheral blood and discarded liver, lymph node, and tonsil tissues from chronic HBV patients undergoing lymph node surgery, hepatectomy, and tonsillectomy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Male or female, patients with chronic hepatitis B and hepatitis B surface antigen negative patients with clinical diagnosis who need to undergo liver, spleen, tonsil or lymph node surgery. 2. Before performing any research-related steps, the patient understood the research process, signed the informed consent, and complied with the research requirements. 3. Patients diagnosed with chronic hepatitis B virus infection according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B(2019 Version)" . Exclusion Criteria: 1. Those concomitant HCV, HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, and autoimmune liver disease , etc. were excluded. 2. Diseases of the immune system or coagulation system, such as hyperthyroidism, diabetes, thrombocytopenic purpura, etc., were excluded. 3. Exclude serious underlying diseases that affect the immune status of the body. 4. The investigator believes that there are other circumstances that are not suitable for inclusion.

Primary outcome measure(s)

The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients — After the tissue section collected
Tissue section from the enrolled patients will be used to detect the levels of HBV-specific immunity and other laboratory indicators after restimulation with HBV peptide pools.

Trial sites (1)

Facility	City	Region	Status
Nanfang hospital, Southern Medical university	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07240350 on ClinicalTrials.gov ↗ ← All trials in China