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

NCT ID: NCT05677724

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-30

Brief 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.

Conditions

HBV; Primary Liver Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

HBV DNA(\>20000IU/mL)

HBV DNA Sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Group 2

HBV DNA(\>2000IU/mL)

HBV DNA Sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Group 3

HBV DNA(10-2000IU/mL)

HBV DNA Sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Group 4

HBV DNA(=\<10IU/mL)

HBV DNA Sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Group 5

HBV DNA(0 IU/mL)

HBV DNA Sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fubing Wang

OTHER

Sponsor Role: lead

Responsible Party

Fubing Wang

Dr.Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fubing Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fubing Wang, Doctor

Role: CONTACT

wfb20042002@sina.com

86-15872385253

Facility Contacts

Fubing Wang, Doctor

Role: primary

wfb20042002@sina.com

86-15872385253

Other Identifiers

20220929

Identifier Type: -

Identifier Source: org_study_id