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

Sponsor
Fubing Wang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05677724
Collaborator
(none)
20
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HBV DNA Sequencing

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

HBV DNA(>20000IU/mL)

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.

Group 2

HBV DNA(>2000IU/mL)

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.

Group 3

HBV DNA(10-2000IU/mL)

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.

Group 4

HBV DNA(=<10IU/mL)

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.

Group 5

HBV DNA(0 IU/mL)

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.

Outcome Measures

Primary Outcome Measures

  1. Biochemical index detection [within 4 hours after the sample was submitted for examination]

    HbsAg (IU/mL) \HbsAb (mIU/mL)\HbeAg\HbeAb\HbcAb

  2. HBV DNA copy number [within 24 hours after the sample was submitted for examination]

    HBV DNA (IU/mL)

  3. single cell RNA sequencing [within 4 hours after the sample was submitted for examination]

    10x genomics chromium 3' sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

Sponsors and Collaborators

  • Fubing Wang

Investigators

  • Principal Investigator: Fubing Wang, Doctor, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fubing Wang, Dr.Prof., Zhongnan Hospital
ClinicalTrials.gov Identifier:
NCT05677724
Other Study ID Numbers:
  • 20220929
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023