Clinical trial NCT05677724: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HBV
Primary Liver Cancer
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Biochemical index detection
timeFrame: within 4 hours after the sample was submitted for examination
measure: HBV DNA copy number
timeFrame: within 24 hours after the sample was submitted for examination
measure: single cell RNA sequencing
timeFrame: within 4 hours after the sample was submitted for examination
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fubing Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: