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

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ClinicalTrials.gov Identifier: NCT05677724
Recruitment Status : Recruiting
First Posted : January 10, 2023
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Fubing Wang, Zhongnan Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
HBV Primary Liver Cancer Diagnostic Test: HBV DNA Sequencing

Study Design
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Study Type : Observational
Estimated 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 : July 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical index detection [ Time Frame: within 4 hours after the sample was submitted for examination ]
    HbsAg (IU/mL) \HbsAb (mIU/mL)\HbeAg\HbeAb\HbcAb

  2. HBV DNA copy number [ Time Frame: within 24 hours after the sample was submitted for examination ]
    HBV DNA (IU/mL)

  3. single cell RNA sequencing [ Time Frame: within 4 hours after the sample was submitted for examination ]
    10x genomics chromium 3' sequencing


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05677724


Contacts
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Contact: Fubing Wang, Doctor 86-15872385253 wfb20042002@sina.com

Locations
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China, Hubei
Zhongnan Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430071
Contact: Fubing Wang, Doctor    86-15872385253    wfb20042002@sina.com   
Sponsors and Collaborators
Fubing Wang
Investigators
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Principal Investigator: Fubing Wang, Doctor Wuhan University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fubing Wang, Dr.Prof., Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT05677724    
Other Study ID Numbers: 20220929
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases