Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC

Not yet recruiting

• Conditions: HCC
• Interventions: Diagnostic Test: No intervention was required for patients or control group in this study

• Registration Number: NCT05840133
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

In this study, the investigators will detect the expression of HBV-related HCC biomarker lncRNA SNHG15 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 lncRNA SNHG15 was detected by RT-PCR. At the same time, healthy subjects were selected as the control group, and lncRNA SNHG15 in blood was detected by RT-PCR. At the same time, the correlation between lncRNA SNHG15 and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Study Start: 2023-09-01
• Primary Completion: 2025-01-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• The age and sex of the healthy control group were matched with that of HBV-associated patient group. There was no tumor in the other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body; the functions of the liver, kidney, and heart were normal.

Exclusion Criteria

• The volunteer has tumors in the liver or other parts of the body, or blood system tumors; The volunteer has benign liver diseases; The patient has inflammatory disease elsewhere. If the volunteer has any one of the above diseases, it shall be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
negative control group	No intervention was required for patients or control group in this study	The age and sex of this group were matched with that of HBV-associated HCC patient group. The patient did not have any tumor but had HBV infection. The functions of the renal and heart were normal.
HBV-associated HCC group	No intervention was required for patients or control group in this study	The age and gender of patients are not limited. The patient was finally diagnosed as HBV-associated HCC by imaging examination and pathology.
Healthy control group	No intervention was required for patients or control group in this study	The age and sex of the healthy control group were matched with that of HBV-associated HCC patient group. There was no tumor in the liver or other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body. The functions of the liver, kidney, and heart were normal.

Primary Outcome Measures

Name	Time	Method
Detection of lncRNA SNHG15 in HBV-associated HCC patients before surgery	1 to 3 days before surgery	The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.

Secondary Outcome Measures

Name	Time	Method
Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery	one week after surgery	1. The expressions of lncRNA SNHG15 in tissues: In the tumor and adjacent tissues from HBV-associated HCC patients, the expressions of lncRNA SNHG15were measured by real-time fluorescence quantitative PCR method.; 2. The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after surgery	6 months postoperatively	The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
Detection of lncRNA SNHG15 in the control groups as baseline	the level of lncRNA SNHG15 were detected as baseline	The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.