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

HCC Clinical Trial

Official title:

The First Affliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05840133
• Other study ID #: YXLL-KY-2023
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Qianfoshan Hospital
• Contact: Chunqing Wang, Dr.
• Phone: 053189269680
• Email: 1150156766[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: December 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• HCC

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

References & Publications (7)

Befeler AS, Di Bisceglie AM. Hepatocellular carcinoma: diagnosis and treatment. Gastroenterology. 2002 May;122(6):1609-19. doi: 10.1053/gast.2002.33411. — View Citation

Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 2017 May 2;166(9):637-648. doi: 10.7326/M16-2575. Epub 2017 Mar 21. — View Citation

Johnson PJ. The role of serum alpha-fetoprotein estimation in the diagnosis and management of hepatocellular carcinoma. Clin Liver Dis. 2001 Feb;5(1):145-59. doi: 10.1016/s1089-3261(05)70158-6. — View Citation

Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27. — View Citation

Prevention of Infection Related Cancer (PIRCA) Group, Specialized Committee of Cancer Prevention and Control, Chinese Preventive Medicine Association; Non-communicable & Chronic Disease Control and Prevention Society, Chinese Preventive Medicine Association; Health Communication Society, Chinese Preventive Medicine Association. [Strategies of primary prevention of liver cancer in China: expert consensus (2018)]. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Jan 6;53(1):36-44. doi: 10.3760/cma.j.issn.0253-3766.2018.07.013. Chinese. — View Citation

Sartorius K, Sartorius B, Aldous C, Govender PS, Madiba TE. Global and country underestimation of hepatocellular carcinoma (HCC) in 2012 and its implications. Cancer Epidemiol. 2015 Jun;39(3):284-90. doi: 10.1016/j.canep.2015.04.006. Epub 2015 Apr 25. — View Citation

Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of lncRNA SNHG15 in HBV-associated HCC patients 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.	1 to 3 days before surgery
Secondary	Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 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.	one week after surgery
Secondary	Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after 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.	6 months postoperatively
Secondary	Detection of lncRNA SNHG15 in the control groups 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.	the level of lncRNA SNHG15 were detected as baseline