Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease
NCT ID: NCT07265544
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
240 participants
OBSERVATIONAL
2023-03-01
2026-02-12
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal group
Age groups are divided into minors (\<18 years old), young adults (18-50 years old), and the elderly (\>65 years old).
Collection of Preoperative Peripheral Blood
Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.
Collection of Discarded Liver Tissue During Surgery
From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.
Fatty liver group
Fatty liver groups are categorized based on the degree of hepatic steatosis into mild, moderate, and severe fatty liver groups.
Collection of Preoperative Peripheral Blood
Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.
Collection of Discarded Liver Tissue During Surgery
From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.
Liver fibrosis group
Liver fibrosis groups are distinguished according to the stage of hepatic fibrosis into mild, moderate, and severe liver fibrosis groups.
Collection of Preoperative Peripheral Blood
Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.
Collection of Discarded Liver Tissue During Surgery
From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.
hepatitis B virus infection
Patients with hepatitis B virus (HBV) infection
Collection of Preoperative Peripheral Blood
Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.
Collection of Discarded Liver Tissue During Surgery
From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.
Interventions
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Collection of Preoperative Peripheral Blood
Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.
Collection of Discarded Liver Tissue During Surgery
From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.
Eligibility Criteria
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Inclusion Criteria
2. No restrictions on age and gender;
3. 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)";
4. 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.
Exclusion Criteria
2. Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.
3. Those with severe underlying diseases that affect the body's immune status will be excluded.
4. Individuals whom the investigator deems unsuitable for participation in this study will be excluded.
ALL
Yes
Sponsors
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Beijing Friendship Hospital
OTHER
Beijing YouAn Hospital
OTHER
Zhongnan Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Nan
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2023-207
Identifier Type: -
Identifier Source: org_study_id
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