Clinical trial NCT05840133: Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC
Official title: The First Affliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HCC
Keywords: HBV related HCC
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of lncRNA SNHG15 in HBV-associated HCC patients before surgery
timeFrame: 1 to 3 days before surgery
Secondary outcomes:
measure: Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery
timeFrame: one week after surgery
measure: Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after surgery
timeFrame: 6 months postoperatively
measure: Detection of lncRNA SNHG15 in the control groups as baseline
timeFrame: the level of lncRNA SNHG15 were detected as baseline
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: ChunqingWang [chunqingwang], Dr
role: PRINCIPAL_INVESTIGATOR
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