HBVNCT05677724
Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
An observational study of HBV and Primary Liver Cancer, run by Fubing Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HBV, Primary Liver Cancer
- What is being tested?
- HBV DNA Sequencing
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fubing Wang, Doctor, 86-15872385253, wfb20042002@sina.com
About this study
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.
- Conditions
- HBV, Primary Liver Cancer
- Being tested
- HBV DNA Sequencing
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV DNA SequencingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | HBV DNA(>20000IU/mL) Receives: Diagnostic Test: HBV DNA Sequencing | |
| Group 2 | HBV DNA(>2000IU/mL) Receives: Diagnostic Test: HBV DNA Sequencing | |
| Group 3 | HBV DNA(10-2000IU/mL) Receives: Diagnostic Test: HBV DNA Sequencing | |
| Group 4 | HBV DNA(=<10IU/mL) Receives: Diagnostic Test: HBV DNA Sequencing | |
| Group 5 | HBV DNA(0 IU/mL) Receives: Diagnostic Test: HBV DNA Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical index detection
HbsAg (IU/mL) \HbsAb (mIU/mL)\HbeAg\HbeAb\HbcAb
Measured: within 4 hours after the sample was submitted for examination
HBV DNA copy number
HBV DNA (IU/mL)
Measured: within 24 hours after the sample was submitted for examination
single cell RNA sequencing
10x genomics chromium 3' sequencing
Measured: within 4 hours after the sample was submitted for examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fubing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fubing Wang, Zhongnan Hospital
- Investigators
- Fubing Wang, Doctor, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677724
- Sponsor's protocol ID
- 20220929
- Status last verified
- Dec 2022
- First submitted
- 18 Oct 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment
- ClinicalTrials.gov ID
- NCT05677724
- Acronym / sponsor ID
- 20220929
- Conditions
- HBV, Primary Liver Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fubing WangUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: HBV DNA SequencingHBV DNA(>20000IU/mL) |
| Group 2 | – | Diagnostic Test: HBV DNA SequencingHBV DNA(>2000IU/mL) |
| Group 3 | – | Diagnostic Test: HBV DNA SequencingHBV DNA(10-2000IU/mL) |
| Group 4 | – | Diagnostic Test: HBV DNA SequencingHBV DNA(=<10IU/mL) |
| Group 5 | – | Diagnostic Test: HBV DNA SequencingHBV DNA(0 IU/mL) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBV DNA SequencingClinical 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. | Diagnostic test | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fubing Wang, Doctor principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV and Primary Liver Cancer, run by Fubing Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fubing Wang, Doctor (86-15872385253, wfb20042002@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical index detection (time frame: within 4 hours after the sample was submitted for examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.