The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection (NCT07240350) | Clinical Trial Compass
RecruitingNot Applicable
The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
China280 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Before performing any research-related steps, the patient understood the research process, signed the informed consent, and complied with the research requirements.
. 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
. Those concomitant HCV, HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, and autoimmune liver disease , etc. were excluded.
. Diseases of the immune system or coagulation system, such as hyperthyroidism, diabetes, thrombocytopenic purpura, etc., were excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients
Timeframe: After the tissue section collected
Trial details
NCT IDNCT07240350
SponsorNanfang Hospital, Southern Medical University