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

Recruiting

• Conditions: Primary Liver Cancer; HBV
• Interventions: Diagnostic Test: HBV DNA Sequencing

• Registration Number: NCT05677724
• Lead Sponsor: Fubing Wang

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 available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-10-18
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	HBV DNA Sequencing	HBV DNA(\>20000IU/mL)
Group 5	HBV DNA Sequencing	HBV DNA(0 IU/mL)
Group 2	HBV DNA Sequencing	HBV DNA(\>2000IU/mL)
Group 3	HBV DNA Sequencing	HBV DNA(10-2000IU/mL)
Group 4	HBV DNA Sequencing	HBV DNA(=\<10IU/mL)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China