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

December 22, 2022 updated by: Fubing Wang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 20 patients with primary liver cancer, including 40 single cell sequencing samples (20 cases of liver cancer tissue and 20 cases of paired peripheral blood), were planned to be included and divided into 5 groups. Groups 1-4 were primary liver cancer complicated with hepatitis B infection, and group 5 were hepatitis B negative liver cancer patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fubing Wang

Investigators

  • Principal Investigator: Fubing Wang, Doctor, Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220929

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Liver Cancer

Clinical Trials on HBV DNA Sequencing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe