Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03227510
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2017-07-20
Brief Title:
MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients
Sponsor:
Peoples Friendship University of Russia
Organization:
Peoples Friendship University of Russia
Study Overview
Official Title:
Circulating MicroRNAs as Biomarkers in Hepatocellular Carcinoma Among Somali Patients
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatocellular carcinoma HCC is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide Although current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound MRI CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein AFP which characterized by very low of sensitivity in the detection of HCC Last two decades scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood
MicroRNAs are class of 20 - 25 nucleotide in length non-coding RNAs and its emerging non-invasive diagnostic biomarker for cancer diagnosing screening monitoring treatment and to predict prognosis A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver pancreatic and colorectal carcinoma Recently MicroRNAs have a role in the development of HCC but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC
The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients and health volunteers and those HCC patients and To determine the clinical utility of MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein the current marker of HCC
MicroRNAs are class of 20 - 25 nucleotide in length non-coding RNAs and its emerging non-invasive diagnostic biomarker for cancer diagnosing screening monitoring treatment and to predict prognosis A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver pancreatic and colorectal carcinoma Recently MicroRNAs have a role in the development of HCC but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC
The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients and health volunteers and those HCC patients and To determine the clinical utility of MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein the current marker of HCC
Detailed Description:
Hepatocellular carcinoma HCC is the most common primary liver cancer and is the third leading cause of cancer that related death in the worldwide According the burden of cancer in economically developing countries is increasing in a result of population aging and growth in addition to increasing the adaptation of cancer-related lifestyle choices such as physical inactivates smoking and western diets Liver cancer in women are seventh most common diagnosed cancer and sixth most cause of cancer death while in men are fifth diagnosed cancer and second cause of cancer death In 2008 liver cancer new cases were estimated 748300 and death cases were 695900 occurred in worldwide Viral hepatitis infections alcohol fungal toxins aflatoxins food additives toxins produced industrial chemicals and water and air pollutants are the major factors of primary liver cancer
Although current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound MRI CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein AFP which characterized by very low of sensitivity in the detection of HCC Last two decades scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood
MicroRNAs are class of 20 - 25 nucleotide in length non-coding RNAs and its emerging non-invasive diagnostic biomarker for cancer diagnosing screening monitoring treatment and to predict prognosis A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver pancreatic and colorectal carcinoma Recently MicroRNAs have a role in the development of HCC but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC
Purpose
1 To recognize serum microRNAs as a diagnosis or prediction biomarker for Hepatocellular carcinoma
2 To correlate with the expression level of microRNAs between HCC patients chronic liver disease and health volunteer subjects
3 To determine the clinical utility of MicroRNAs as a diagnostic maker of Hepatocellular carcinoma comparing with alpha fetoprotein the current marker of HCC
Methods Study design This is observational study Case Control Study A total of 126 subjects aged over 18 years old that divided into three groups will be enrolled in this study in Dufle Specialist Hospital these groups are HCC group Chronic liver disease group and health volunteer group The diagnosed criteria of HCC group are ultrasound which its nodules more than 5cm liver function tests viral markers and AFP The other groups chronic liver disease and health the diagnoses will be based on laboratory such as liver function tests viral markers AFP complete blood count CBC Kidney functions and others the clinical and laboratory analysis data will be collected perceptively The blood samples will be collected at one time after that the blood samples will be separated using Serum-separating tubes and then centrifuges to get the serum and will be stored in -20C before transferred from Somalia to Russia
Viral marker Hepatitis B surface antigen HBsAg and antibody to HCV anti-HCV will be checked using commercially available enzyme linked immunosorbent assay kits for every subject of these three groups
The expression of MicroRNAs will be detected by quantitative reverse-transcriptase polymerase chain reaction qRT-PCR with human TaqMan MicroRNA Assay Kits Applied Biosystems of these groups either HCC group Chronic liver disease and healthy volunteers The investigators will define the groups of HCC Chronic liver disease and healthy volunteers with high or low expression based on the median expression value of each microRNA
All statistical analyses will be carried out with Statistical Package for the Social Sciences SPSS version 20 MicroRNAs expressions among different group HCC Chronic liver diseases and healthy volunteers will be analyzed by SPSS
Although current most of doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound MRI CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein AFP which characterized by very low of sensitivity in the detection of HCC Last two decades scientists was focused researches of small molecules called MicroRNAs which are produced by human cells and can be released in the blood
MicroRNAs are class of 20 - 25 nucleotide in length non-coding RNAs and its emerging non-invasive diagnostic biomarker for cancer diagnosing screening monitoring treatment and to predict prognosis A number of studies exposed an abnormal expression of human serum MicroRNAs in many tumors such as liver pancreatic and colorectal carcinoma Recently MicroRNAs have a role in the development of HCC but still it is unknown if these small molecules will be used as biomarker for diagnosis and survival of HCC
Purpose
1 To recognize serum microRNAs as a diagnosis or prediction biomarker for Hepatocellular carcinoma
2 To correlate with the expression level of microRNAs between HCC patients chronic liver disease and health volunteer subjects
3 To determine the clinical utility of MicroRNAs as a diagnostic maker of Hepatocellular carcinoma comparing with alpha fetoprotein the current marker of HCC
Methods Study design This is observational study Case Control Study A total of 126 subjects aged over 18 years old that divided into three groups will be enrolled in this study in Dufle Specialist Hospital these groups are HCC group Chronic liver disease group and health volunteer group The diagnosed criteria of HCC group are ultrasound which its nodules more than 5cm liver function tests viral markers and AFP The other groups chronic liver disease and health the diagnoses will be based on laboratory such as liver function tests viral markers AFP complete blood count CBC Kidney functions and others the clinical and laboratory analysis data will be collected perceptively The blood samples will be collected at one time after that the blood samples will be separated using Serum-separating tubes and then centrifuges to get the serum and will be stored in -20C before transferred from Somalia to Russia
Viral marker Hepatitis B surface antigen HBsAg and antibody to HCV anti-HCV will be checked using commercially available enzyme linked immunosorbent assay kits for every subject of these three groups
The expression of MicroRNAs will be detected by quantitative reverse-transcriptase polymerase chain reaction qRT-PCR with human TaqMan MicroRNA Assay Kits Applied Biosystems of these groups either HCC group Chronic liver disease and healthy volunteers The investigators will define the groups of HCC Chronic liver disease and healthy volunteers with high or low expression based on the median expression value of each microRNA
All statistical analyses will be carried out with Statistical Package for the Social Sciences SPSS version 20 MicroRNAs expressions among different group HCC Chronic liver diseases and healthy volunteers will be analyzed by SPSS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None