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

NCT05840133 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2023
• Study Type: observational
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HCC

Keywords

HBV related HCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery

  one week after surgery

• Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after surgery

  6 months postoperatively

• Detection of lncRNA SNHG15 in the control groups as baseline

  the level of lncRNA SNHG15 were detected as baseline

Study Arms (3)

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

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

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

Interventions

No intervention was required for patients or control group in this study DIAGNOSTIC_TEST

The patient was treated normally and no intervention was required in this study

HBV-associated HCC group; Healthy control group; negative control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (7)

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

  PMID: 30970190 BACKGROUND

• 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.

  PMID: 25922178 BACKGROUND

• 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.

  PMID: 28319996 BACKGROUND

• 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.

  PMID: 29599078 BACKGROUND

• 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.

  PMID: 30605974 BACKGROUND

• 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.

  PMID: 11218912 BACKGROUND

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

  PMID: 12016426 BACKGROUND

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.

Study Officials

• ChunqingWang [chunqingwang], Dr

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunqing Wang, Dr.

CONTACT

053189269680; 1150156766@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intermediate technician

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: September 1, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share