- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677724
Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fubing Wang, Doctor
- Phone Number: 86-15872385253
- Email: wfb20042002@sina.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430071
- Recruiting
- Zhongnan Hospital of Wuhan University
-
Contact:
- Fubing Wang, Doctor
- Phone Number: 86-15872385253
- Email: wfb20042002@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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)
|
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)
|
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)
|
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)
|
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)
|
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
Sponsor
Investigators
- Principal Investigator: Fubing Wang, Doctor, Wuhan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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