Study of Serum Tumor Markers of HBV Associated HCC

April 10, 2023 updated by: Qianfoshan Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

the patients admitted to the First Affiliated Hospital of Shandong First Medical University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HBV-associated HCC group
The patient was finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.
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.
negative control group
HBV positive but not HCC
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.
Healthy control group
Healthy crowd
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of RNA and protein for diagnosis
Time Frame: 6 months
Detect the content of the RNA and protein in tumor and serum
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

January 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YXLL-KY-2023(026)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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