Actively Recruiting
The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-04-16
280
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the structure and immune cell composition of germinal centers in individuals with chronic hepatitis B virus (HBV) infection. The study focuses on understanding the types, functions, and diversity of B cell clones within these germinal centers, and whether ectopic germinal centers exist in the livers of chronic HBV patients. This observational study aims to compare immune responses between those with chronic HBV infection and HBV-negative individuals. The study involves collecting discarded tissues including liver, spleen, tonsil, and lymph nodes from patients undergoing surgeries such as hepatectomy, tonsillectomy, splenectomy, or lymph node dissection. Both chronic HBV-infected and HBV-negative patients undergoing these procedures are included. No additional treatment is administered as part of the study; clinical care decisions remain with the treating physicians. Tissue samples and peripheral blood will be analyzed to assess immune cell characteristics and HBV antigen specificity. Participants undergo standard clinical procedures, with 30 milliliters of peripheral blood drawn before surgery and discarded tissues collected during surgery for research. Medical history, physical exams, and demographic data are recorded. Researchers will measure HBV-specific immune responses and examine transcriptomic and proteomic differences in germinal center tissues. Safety monitoring includes tracking any adverse medical events during the clinical care period. The study plans to enroll 280 participants and follows routine clinical practice without requiring extra visits or laboratory tests.
CONDITIONS
Brief Title
The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients with chronic hepatitis B or hepatitis B surface antigen negative patients needing liver, spleen, tonsil, or lymph node surgery
- Patients who understand the research process, sign informed consent, and agree to comply with study requirements
- Patients diagnosed with chronic hepatitis B virus infection according to the 2019 guidelines
You will not qualify if you...
- Patients with hepatitis C virus, HIV infection, alcoholic or non-alcoholic fatty liver disease, or autoimmune liver disease
- Patients with immune system or coagulation disorders such as hyperthyroidism, diabetes, or thrombocytopenic purpura
- Patients with serious underlying diseases affecting immune status
- Any other conditions deemed unsuitable for inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Day of surgery
Participants undergo surgery as part of routine clinical care during which discarded liver, spleen, tonsil, or lymph node tissues are collected for research purposes. Peripheral blood samples are also collected before surgery.
1 visit (in-person) on the day of surgery
Duration - Ongoing during routine clinical care
Participants are observed through review of medical records and routine lab reports without additional study visits or interventions.
No additional visits beyond routine clinical care
Trial Site Locations
Total: 1 location
1
Nanfang hospital, Southern Medical university
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Y
Yongyin Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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