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

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

Tracking Information

• First Submitted Date: October 18, 2022
• First Posted Date: January 10, 2023
• Last Update Posted Date: January 10, 2023
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2022)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
• Official Title: Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• HBV
• Primary Liver Cancer

Intervention

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.

Study Groups/Cohorts

• Group 1
  HBV DNA(>20000IU/mL)
  Intervention: Diagnostic Test: HBV DNA Sequencing
• Group 2
  HBV DNA(>2000IU/mL)
  Intervention: Diagnostic Test: HBV DNA Sequencing
• Group 3
  HBV DNA(10-2000IU/mL)
  Intervention: Diagnostic Test: HBV DNA Sequencing
• Group 4
  HBV DNA(=<10IU/mL)
  Intervention: Diagnostic Test: HBV DNA Sequencing
• Group 5
  HBV DNA(0 IU/mL)
  Intervention: Diagnostic Test: HBV DNA Sequencing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 22, 2022): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05677724
• Other Study ID Numbers: 20220929
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fubing Wang, Zhongnan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Fubing Wang
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Fubing Wang, Doctor; Wuhan University

• PRS Account: Zhongnan Hospital
• Verification Date: December 2022