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
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Condition or disease | Intervention/treatment |
---|---|
HBV Primary Liver Cancer | Diagnostic Test: HBV DNA Sequencing |
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 |
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. |
- 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
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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 |
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.
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
Contact: Fubing Wang, Doctor | 86-15872385253 | wfb20042002@sina.com |
China, Hubei | |
Zhongnan Hospital of Wuhan University | Recruiting |
Wuhan, Hubei, China, 430071 | |
Contact: Fubing Wang, Doctor 86-15872385253 wfb20042002@sina.com |
Principal Investigator: | Fubing Wang, Doctor | Wuhan University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |