Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment

HBV Clinical Trial

Official title:

Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677724
• Other study ID #: 20220929
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: Zhongnan Hospital
• Contact: Fubing Wang, Doctor
• Phone: 86-15872385253
• Email: wfb20042002[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In summary, with the help of single-cell sequencing technology, this study aims to focus on elucidating the influence of HBV-induced hepatocellular carcinoma cell metabolic changes on microenvironment remodeling. With the help of hepatocellular carcinoma microenvironment changes, this study provide a more accurate diagnosis and treatment method for HBV-induced hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with primary liver cancer (hepatocellular carcinoma (HCC)), with evidence of histological or cytological diagnosis, or with HCC meeting conventional clinical diagnostic criteria.
• Both sexes, aged 18-80 years old
• The results of HBVDNA test were in line with the inclusion criteria
• The patient had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST V1.1)
• Agreed to comply with the study protocol for treatment and follow-up, agreed to provide clinicopathological and follow-up data required by the study, and agreed to use the study data for subsequent research and product development

Exclusion Criteria:

• Other malignant tumors;
• Patients with severe organic diseases do not meet the requirements of infectious liver cancer in this study;
• Suffering from mental illness cannot guarantee the compliance of this study;
• Previous recipients of any cell or organ transplantation;
• Received local regional liver therapy (including various ablations, percutaneous ethanol or acetic acid injections, high-intensity focused ultrasound, transarterial embolization, chemotherapy, or chemoembolization plus embolization) within 14 days prior to study treatment initiation.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HBV
• Primary Liver Cancer

Intervention

Diagnostic Test:
• HBV DNA Sequencing
Clinical surgical specimens were obtained, cleaned briefly and transported to the laboratory. Single-cell suspension preparation and blood cell separation were performed, single-cell sorting suspension was prepared and put on the machine, sorting and library construction were performed, and mRNA sequencing adaptor was docked. Single cell data analysis. Based on the findings of single cell analysis, functional verification tests of tumor immune microenvironment cell groups and functional changes of tumor cells were designed.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Fubing Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical index detection	HbsAg (IU/mL) \HbsAb (mIU/mL)\HbeAg\HbeAb\HbcAb	within 4 hours after the sample was submitted for examination
Primary	HBV DNA copy number	HBV DNA (IU/mL)	within 24 hours after the sample was submitted for examination
Primary	single cell RNA sequencing	10x genomics chromium 3' sequencing	within 4 hours after the sample was submitted for examination