Description

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.

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 encompass 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/functional impairment/loss of ability to work; Congenital abnormalities or birth defects; Other important medical events (defined as events that pose a hazard to the subject or require intervention to prevent any of the above situations).