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NCT05825196 Clinical Trial

Study of Serum Tumor Markers of HBV Associated HCC

HCC Clinical Trial

Official title:
Study of Serum Tumor Markers of HBV Associated HCC

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05825196
Other study ID # YXLL-KY-2023(026)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2025

Study information
Verified date April 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 164
Est. completion date December 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• tumor tissue and blood tests
In this study, we need to collect an extra tube of blood for routine testing and the tissue after completion of pathological examination.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Qianfoshan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of RNA and protein for diagnosis Detect the content of the RNA and protein in tumor and serum 6 months
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