NCT05825196

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

March 26, 2023

Last Update Submit

April 10, 2023

Conditions

HCC

Keywords

HBV related HCC

Outcome Measures

Primary Outcomes (1)

  • Detection of RNA and protein for diagnosis

    Detect the content of the RNA and protein in tumor and serum

    6 months

Study Arms (3)

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

negative control group

HBV positive but not HCC

Diagnostic Test: tumor tissue and blood tests

Healthy control group

Healthy crowd

Diagnostic Test: tumor tissue and blood tests

Interventions

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.

HBV-associated HCC groupHealthy control groupnegative control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Paired tumor, adjacent non-tumor liver tissues and blood samples from a cohort of HBV-related HCC patients, and blood samples from healthy subjects were selected as control group.

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 24, 2023

Study Start

May 1, 2023

Primary Completion

January 31, 2025

Study Completion

December 31, 2025

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share