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

Study Overview
=================
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.

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

Conditions
-----------------
HBV, Primary Liver Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: HBV DNA Sequencing


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>HBV DNA(>20000IU/mL) | Diagnostic Test: HBV DNA Sequencing<br>* 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.<br>|
| Group 2<br>HBV DNA(>2000IU/mL) | Diagnostic Test: HBV DNA Sequencing<br>* 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.<br>|
| Group 3<br>HBV DNA(10-2000IU/mL) | Diagnostic Test: HBV DNA Sequencing<br>* 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.<br>|
| Group 4<br>HBV DNA(=<10IU/mL) | Diagnostic Test: HBV DNA Sequencing<br>* 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.<br>|
| Group 5<br>HBV DNA(0 IU/mL) | Diagnostic Test: HBV DNA Sequencing<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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