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

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05840133
Collaborator
(none)
156
52

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: No intervention was required for patients or control group in this study

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 Design

Study Type:
Observational
Anticipated Enrollment :
156 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The First Affliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
HBV-associated HCC group

The age and gender of patients are not limited. The patient was finally diagnosed as HBV-associated HCC by imaging examination and pathology.

Diagnostic Test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study

negative control group

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.

Diagnostic Test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study

Healthy control group

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.

Diagnostic Test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery [one week after surgery]

    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. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

  • Principal Investigator: ChunqingWang [chunqingwang], Dr, Qianfoshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ChunqingWang, Intermediate technician, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05840133
Other Study ID Numbers:
  • YXLL-KY-2023
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ChunqingWang, Intermediate technician, Qianfoshan Hospital

Study Results

No Results Posted as of May 3, 2023