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临床试验/NCT07265544
NCT07265544招募中不适用

Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
Change From Control in Liver Inflammation Degree at Postoperative

研究概览

简要总结

The purpose of this observational study is to employ single-cell multi-omics and spatial omics technologies to characterize the spatial and immune structures within the livers of patients with fatty liver, hepatic hemangioma, focal nodular hyperplasia, liver fibrosis, cirrhosis, and HBV infection. The primary questions it aims to address are:

Investigate the mechanisms of liver degenerative changes during the processes of liver aging, fatty liver, HBV infection, liver fibrosis, and cirrhosis.

Characterize the molecular features and cellular networks at different stages of liver degeneration and identify new targets and mechanisms for the cure of the aforementioned diseases.

The study will collect peripheral blood and discarded liver tissue from patients with hepatic hemangioma, fatty liver, HBV infection, liver fibrosis, and cirrhosis who are undergoing hepatectomy or liver biopsy.

详细描述

Research Objectives The purpose of this study is to leverage the strengths of clinical departments to collect preoperative peripheral blood samples and liver tissue (from hepatectomy or liver biopsy) that meet the project requirements from patients with hepatic hemangioma, focal nodular hyperplasia, fatty liver, HBV infection, liver fibrosis, and cirrhosis. This initiative aims to establish a large-scale clinical liver disease sample repository comprising 160-240 cases. The study will encompass livers across different age groups (including minors under 18 years old, adults aged 18-50 years, and the elderly over 65 years old) and varying severities of fatty liver (mild, moderate, severe), HBV infection, and liver fibrosis (early, moderate, advanced [cirrhosis]). Utilizing single-cell multi-omics (such as single-cell transcriptomics and chromatin accessibility sequencing) and spatial omics sequencing technologies, the study will construct a human spatiotemporal liver degeneration-regeneration atlas covering states of homeostasis, aging, liver fibrosis, and fatty liver. By comparing phenotypes, functions, spatial distributions, and intercellular interactions of cell populations across different groups, the study aims to identify diagnostic and therapeutic targets for cell therapy, gene therapy, or other interventions. 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 Given that this is a multicenter, prospective, observational 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. Researchers 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 Fibrosis-1, Fibrosis-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 Tissue During Surgery: From subjects undergoing hepatectomy or liver biopsy, collect discarded liver tissue during the surgical procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Voluntarily signed the informed consent form;
  • No restrictions on age and gender;
  • Patients diagnosed with hepatic hemangioma or focal nodular hyperplasia of the liver in accordance with the "Guidelines for the Diagnosis and Treatment of Focal Liver Lesions (2014 Edition)" and the "Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition)";
  • Patients with hepatic hemangioma, focal nodular hyperplasia of the liver, fatty liver, HBV infection, liver fibrosis, and cirrhosis who clinically require liver surgery or liver biopsy.

排除标准

  • Individuals with concurrent infections such as HIV will be excluded.
  • Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.
  • Those with severe underlying diseases that affect the body's immune status will be excluded.
  • Individuals whom the investigator deems unsuitable for participation in this study will be excluded.

研究组 & 干预措施

Liver fibrosis group

Liver fibrosis groups are distinguished according to the stage of hepatic fibrosis into mild, moderate, and severe liver fibrosis groups.

干预措施: Collection of Discarded Liver Tissue During Surgery (Procedure)

Normal group

Age groups are divided into minors (<18 years old), young adults (18-50 years old), and the elderly (>65 years old).

干预措施: Collection of Discarded Liver Tissue During Surgery (Procedure)

Liver fibrosis group

Liver fibrosis groups are distinguished according to the stage of hepatic fibrosis into mild, moderate, and severe liver fibrosis groups.

干预措施: Collection of Preoperative Peripheral Blood (Procedure)

hepatitis B virus infection

Patients with hepatitis B virus (HBV) infection

干预措施: Collection of Preoperative Peripheral Blood (Procedure)

hepatitis B virus infection

Patients with hepatitis B virus (HBV) infection

干预措施: Collection of Discarded Liver Tissue During Surgery (Procedure)

Fatty liver group

Fatty liver groups are categorized based on the degree of hepatic steatosis into mild, moderate, and severe fatty liver groups.

干预措施: Collection of Preoperative Peripheral Blood (Procedure)

Fatty liver group

Fatty liver groups are categorized based on the degree of hepatic steatosis into mild, moderate, and severe fatty liver groups.

干预措施: Collection of Discarded Liver Tissue During Surgery (Procedure)

Normal group

Age groups are divided into minors (<18 years old), young adults (18-50 years old), and the elderly (>65 years old).

干预措施: Collection of Preoperative Peripheral Blood (Procedure)

结局指标

主要结局

Change From Control in Liver Inflammation Degree at Postoperative

时间窗: immediately after the surgery

Postoperative liver tissue collection for the assessment of hepatic inflammation in participants.

次要结局

  • Change From Control in Hepatocyte Senescence Score at Postoperative(immediately after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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