Hepatitis B Virus InfectionNCT07240350
The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
An observational study of Hepatitis B Virus Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Virus Infection
- What is being tested?
- Tissue resection
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 12 Feb 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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)" .
Who cannot join
- 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.
- Exclude serious underlying diseases that affect the immune status of the body.
- The investigator believes that there are other circumstances that are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital, Southern Medical university
Guangzhou, Guangdong, 510515
Yongyin Li, +8613826039505, yongyinli@foxmail.com
About this study
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.
Read the detailed description
This study is a single-center, prospective, cross-sectional investigation. We plan to enroll 280 participants.By collecting discarded liver, spleen, tonsil, and lymph node tissues from chronic HBV-infected and HBsAg-negative patients postoperatively, the investigators aim to compare the phenotypic and functional differences of various immune cells in the germinal centers of these organs between the two groups. The investigators will also identify the HBV antigen specificity of B cell clones in different germinal centers. Additionally, the investigators will observe the structural, transcriptomic, and proteomic differences in germinal center tissues between the two groups to elucidate the impact of chronic HBV infection on germinal centers. During the study, no random or protocol-driven treatments will be administered to participants. If clinically appropriate, the treating physician will make decisions and select treatment plans based on individual circumstances.
Data Collection Procedures Since this is a single-center, prospective, cross-sectional study, no additional visits or laboratory analyses beyond routine clinical practice are required. Physicians will determine treatment plans in accordance with instructions and local guidelines. The investigators will review patients' medical histories and laboratory reports to determine eligibility based on inclusion and exclusion criteria. Patients must sign the most recent informed consent form (ICF) approved by the IRB/IEC before data collection. In line with routine clinical practice, surgeons will prioritize clinical needs when obtaining surgical specimens, and then collect discarded clinical samples for experimental exploration and clinical data analysis. Each participant will be assigned a unique identification number, such as HBV-liver/tonsil/LN/spleen-1, HBV-liver/tonsil/LN/spleen-2, HC-liver/tonsil/LN/spleen-1, HC-liver/tonsil/LN/spleen-2, etc. All study documents (e.g., case report forms, clinical records) will use this identification number. In compliance with data privacy regulations, the use of unique identification numbers is permitted as long as they do not contain combinations of information that could identify participants (for example, the use of participants' initials and date of birth together is not allowed).
Sample Collection Demographic Data Recording: Record date of birth, gender, and initials. Medical History and Physical Examination: Include vital signs, height, weight, physical examination of all body systems; past and present medical history, including the presence of spider angiomas or palmar erythema, dull complexion, jaundice of skin and sclera, hepatic pain, and enlargement of liver, spleen, or lymph nodes.
Preoperative Peripheral Blood Collection: Draw 30 milliliters of peripheral blood from the subject's upper limb before surgery.
Collection of Discarded Liver , Spleen ,Tonsil, Lymph Node Tissue During Surgery: From subjects undergoing hepatectomy, tonsillectomy, splenectomy, or lymph node dissection, collect discarded liver, spleen ,tonsil, lymph node tissue during the surgical procedure.
Safety Monitoring, Reporting, and Medical Management Adverse Event (AE) Definition: An adverse event is any unfavorable medical occurrence in a patient or subject after the administration of a drug, whether or not considered related to the treatment. Adverse events can include any adverse signs (including abnormal laboratory findings), symptoms, or diseases temporally related to the use of the study drug, regardless of whether a causal relationship with the study drug is considered. Adverse events include both serious adverse events (SAEs) and non-serious adverse events.
SAE Definition: An SAE is a medical event occurring during a clinical study that requires hospitalization or prolongation of hospital stay, results in disability, affects the ability to work, is life-threatening or fatal, or causes congenital anomalies. These medical events include:
Events leading to death; Life-threatening events (defined as events where the subject is at immediate risk of death at the time of the event); Events requiring hospitalization or prolongation of hospital stay; Events that may result in permanent or significant disability
- Conditions
- Hepatitis B Virus Infection
- Being tested
- Tissue resection
- Keywords
- Germinal center, humoral immunity, immune response, hepatitis B virus infection
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue resectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| HBV patients who underwent liver, spleen, tonsil, and lymph node surgery | The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery. Receives: Procedure: Tissue resection | |
| Healthy patients who underwent liver, spleen, tonsil, and lymph node surgery | The group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery. Receives: Procedure: Tissue resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients
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.
Measured: After the tissue section collected
Secondary outcomes (1)
Germinal center organization transcriptomics will be measured using the tissue section of the enrolled patients
We will utilize tissue samples and employ experimental methods such as immunohistochemistry, immunofluorescence, and spatial transcriptomics to measure the structure and size of germinal centers.
Measured: After the tissue section collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240350
- Sponsor's protocol ID
- NFEC-2022-279
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Regulatory Mechanism of Germinal Center Immune Response in Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT07240350
- Acronym / sponsor ID
- NFEC-2022-279
- Conditions
- Hepatitis B Virus Infection
- Keywords
- Germinal center, humoral immunity, immune response, hepatitis B virus infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-center, prospective, cross-sectional investigation. We plan to enroll 280 participants.By collecting discarded liver, spleen, tonsil, and lymph node tissues from chronic HBV-infected and HBsAg-negative patients postoperatively, the investigators aim to compare the phenotypic and functional differences of various immune cells in the germinal centers of these organs between the two groups. The investigators will also identify the HBV antigen specificity of B cell clones in different germinal centers. Additionally, the investigators will observe the structural, transcriptomic, and proteomic differences in germinal center tissues between the two groups to elucidate the impact of chronic HBV infection on germinal centers. During the study, no random or protocol-driven treatments will be administered to participants. If clinically appropriate, the treating physician will make decisions and select treatment plans based on individual circumstances.
Data Collection Procedures Since this is a single-center, prospective, cross-sectional study, no additional visits or laboratory analyses beyond routine clinical practice are required. Physicians will determine treatment plans in accordance with instructions and local guidelines. The investigators will review patients' medical histories and laboratory reports to determine eligibility based on inclusion and exclusion criteria. Patients must sign the most recent informed consent form (ICF) approved by the IRB/IEC before data collection. In line with routine clinical practice, surgeons will prioritize clinical needs when obtaining surgical specimens, and then collect discarded clinical samples for experimental exploration and clinical data analysis. Each participant will be assigned a unique identification number, such as HBV-liver/tonsil/LN/spleen-1, HBV-liver/tonsil/LN/spleen-2, HC-liver/tonsil/LN/spleen-1, HC-liver/tonsil/LN/spleen-2, etc. All study documents (e.g., case report forms, clinical records) will use this identification number. In compliance with data privacy regulations, the use of unique identification numbers is permitted as long as they do not contain combinations of information that could identify participants (for example, the use of participants' initials and date of birth together is not allowed).
Sample Collection Demographic Data Recording: Record date of birth, gender, and initials. Medical History and Physical Examination: Include vital signs, height, weight, physical examination of all body systems; past and present medical history, including the presence of spider angiomas or palmar erythema, dull complexion, jaundice of skin and sclera, hepatic pain, and enlargement of liver, spleen, or lymph nodes.
Preoperative Peripheral Blood Collection: Draw 30 milliliters of peripheral blood from the subject's upper limb before surgery.
Collection of Discarded Liver , Spleen ,Tonsil, Lymph Node Tissue During Surgery: From subjects undergoing hepatectomy, tonsillectomy, splenectomy, or lymph node dissection, collect discarded liver, spleen ,tonsil, lymph node tissue during the surgical procedure.
Safety Monitoring, Reporting, and Medical Management Adverse Event (AE) Definition: An adverse event is any unfavorable medical occurrence in a patient or subject after the administration of a drug, whether or not considered related to the treatment. Adverse events can include any adverse signs (including abnormal laboratory findings), symptoms, or diseases temporally related to the use of the study drug, regardless of whether a causal relationship with the study drug is considered. Adverse events include both serious adverse events (SAEs) and non-serious adverse events.
SAE Definition: An SAE is a medical event occurring during a clinical study that requires hospitalization or prolongation of hospital stay, results in disability, affects the ability to work, is life-threatening or fatal, or causes congenital anomalies. These medical events include:
Events leading to death; Life-threatening events (defined as events where the subject is at immediate risk of death at the time of the event); Events requiring hospitalization or prolongation of hospital stay; Events that may result in permanent or significant disability
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBV patients who underwent liver, spleen, tonsil, and lymph node surgery | – | Procedure: Tissue resectionThe group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery. |
| Healthy patients who underwent liver, spleen, tonsil, and lymph node surgery | – | Procedure: Tissue resectionThe group of HBV patients who underwent liver, spleen, tonsil, and lymph node surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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)" .
Key exclusion criteria (4 listed)
- 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.
- Exclude serious underlying diseases that affect the immune status of the body.
- The investigator believes that there are other circumstances that are not suitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue resectionThe 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 | Procedure or surgery | HBV patients who underwent liver, spleen, tonsil, and lymph node surgery, Healthy patients who underwent liver, spleen, tonsil, and lymph node surgery |
Primary outcome
The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients
Time frame: 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.
1 secondary outcome
Germinal center organization transcriptomics will be measured using the tissue section of the enrolled patients
Time frame: After the tissue section collected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Virus Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongyin Li (+8613826039505, yongyinli@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients (time frame: After the tissue section collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.