HCCNCT05825196
Study of Serum Tumor Markers of HBV Associated HCC
An observational study of HCC, run by Qianfoshan Hospital.
Trial summary
In this study, the investigators will detect the expression of four potential HBV-related HCC biomarkers: PGIR,FAM3C,LAMB1 and SDC4 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HCC
- What is being tested?
- tumor tissue and blood tests
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the patients admitted to the First Affiliated Hospital of Shandong First Medical University
Who may be able to join
- No local or systemic treatment was performed before surgery. The patients were finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.
Who cannot join
- Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.
About this study
In this study, the investigators will detect the expression of four potential HBV-related HCC biomarkers: PGIR,FAM3C,LAMB1 and SDC4 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.
Read the detailed description
Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and the mRNA and protein expressions of the PGIR,FAM3C,LAMB1 and SDC4 biomarkers in tissues were detected by RT-PCR, western Blot and immunohistochemical analysis. At the same time, healthy subjects were selected as the control group, and mRNA and protein expression levels of the above molecules in blood were detected by RT-PCR and ELISA. At the same time, the correlation between the above biomarkers and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.
- Conditions
- HCC
- Being tested
- tumor tissue and blood tests
- Keywords
- HBV related HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor tissue and blood testsDiagnostic test
In this study, we need to collect an extra tube of blood for routine testing and the tissue after completion of pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| HBV-associated HCC group | The patient was finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete. Receives: Diagnostic Test: tumor tissue and blood tests | |
| negative control group | HBV positive but not HCC Receives: Diagnostic Test: tumor tissue and blood tests | |
| Healthy control group | Healthy crowd Receives: Diagnostic Test: tumor tissue and blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of RNA and protein for diagnosis
Detect the content of the RNA and protein in tumor and serum
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825196
- Sponsor's protocol ID
- YXLL-KY-2023(026)
- Status last verified
- Apr 2023
- First submitted
- 26 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Tumor Markers of HBV Associated HCC
- ClinicalTrials.gov ID
- NCT05825196
- Acronym / sponsor ID
- YXLL-KY-2023(026)
- Conditions
- HCC
- Keywords
- HBV related HCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 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 this study, the investigators will detect the expression of four potential HBV-related HCC biomarkers: PGIR,FAM3C,LAMB1 and SDC4 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.
Detailed description
Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and the mRNA and protein expressions of the PGIR,FAM3C,LAMB1 and SDC4 biomarkers in tissues were detected by RT-PCR, western Blot and immunohistochemical analysis. At the same time, healthy subjects were selected as the control group, and mRNA and protein expression levels of the above molecules in blood were detected by RT-PCR and ELISA. At the same time, the correlation between the above biomarkers and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBV-associated HCC group | – | Diagnostic Test: tumor tissue and blood testsThe patient was finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete. |
| negative control group | – | Diagnostic Test: tumor tissue and blood testsHBV positive but not HCC |
| Healthy control group | – | Diagnostic Test: tumor tissue and blood testsHealthy crowd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the patients admitted to the First Affiliated Hospital of Shandong First Medical University
Key inclusion criteria (1 listed)
- No local or systemic treatment was performed before surgery. The patients were finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.
Key exclusion criteria (1 listed)
- Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.
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 |
|---|---|---|
| tumor tissue and blood testsIn this study, we need to collect an extra tube of blood for routine testing and the tissue after completion of pathological examination. | Diagnostic test | HBV-associated HCC group, Healthy control group, negative control group |
Primary outcome
Detection of RNA and protein for diagnosis
Time frame: 6 months
Detect the content of the RNA and protein in tumor and serum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Qianfoshan Hospital.
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 1 inclusion and 1 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of RNA and protein for diagnosis (time frame: 6 months). 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 24 Apr 2023.