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临床试验/NCT07240350
NCT07240350招募中不适用

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

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2021年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
280
试验地点
1
主要终点
The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)" .

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Tissue resection (Procedure)

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.

干预措施: Tissue resection (Procedure)

结局指标

主要结局

The HBV-specific immune response levels will be measured using the immune cells from lymphoid follicle of the enrolled patients

时间窗: 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.

次要结局

  • Germinal center organization transcriptomics will be measured using the tissue section of the enrolled patients(After the tissue section collected)
  • Germinal center organization structure, transcriptomics and proteomics will be measured using the tissue section of the enrolled patients(After the tissue section collected)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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