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Trial Title:
Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
NCT ID:
NCT05677724
Condition:
HBV
Primary Liver Cancer
Conditions: Official terms:
Carcinoma, Hepatocellular
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HBV DNA Sequencing
Description:
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.
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
Arm group label:
Group 4
Arm group label:
Group 5
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Fubing Wang, Doctor
Phone:
86-15872385253
Email:
wfb20042002@sina.com
Start date:
July 1, 2022
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Fubing Wang
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05677724
