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

NCT07265544 | Recruiting DMC

• 1 other identifier: NFEC-2023-207
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Neoplasm; HBV Infection; Non-alcoholic Fatty Liver Disease NAFLD; Liver Fibrosis

Keywords

single-cell multi-omics; HBV infection; liver degenerative changes

Outcome Measures

Primary Outcomes (1)

• Change From Control in Liver Inflammation Degree at Postoperative

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

  immediately after the surgery

Secondary Outcomes (1)

• Change From Control in Hepatocyte Senescence Score at Postoperative

  immediately after the surgery

Study Arms (4)

Normal group

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

Procedure: Collection of Preoperative Peripheral Blood; Procedure: Collection of Discarded Liver Tissue During Surgery

Fatty liver group

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

Procedure: Collection of Preoperative Peripheral Blood; Procedure: Collection of Discarded Liver Tissue During Surgery

Liver fibrosis group

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

Procedure: Collection of Preoperative Peripheral Blood; Procedure: Collection of Discarded Liver Tissue During Surgery

hepatitis B virus infection

Patients with hepatitis B virus (HBV) infection

Procedure: Collection of Preoperative Peripheral Blood; Procedure: Collection of Discarded Liver Tissue During Surgery

Interventions

Collection of Preoperative Peripheral Blood PROCEDURE

Prior to surgery, 30 milliliters of peripheral blood will be drawn from the subject's upper limb.

Fatty liver group; Liver fibrosis group; Normal group; hepatitis B virus infection

Collection of Discarded Liver Tissue During Surgery PROCEDURE

From subjects undergoing hepatectomy or liver biopsy, discarded liver tissue will be collected during the surgical procedure.

Fatty liver group; Liver fibrosis group; Normal group; hepatitis B virus infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatic hemangioma, focal nodular hyperplasia, fatty liver, HBV infection, liver fibrosis, or cirrhosis who are undergoing hepatectomy or liver biopsy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Beijing Friendship Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• Zhongnan Hospital: collaborator
• Guangzhou General Hospital of Guangzhou Military Command: collaborator

Study Sites (1)

Nan

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yongyin Li, Dr.

CONTACT

+8613826039505; yongyinli@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: December 5, 2025
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 12, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)