MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients

NCT ID: NCT03227510

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-09-30

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).

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 748,300 and death cases were 695,900 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 -20°C 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HCC Cases (Group 1)

This group will include 63 subjects and the diagnoses will be based on clinical examination, laboratory tests such as (Liver Function tests, Alpha-fetoprotein , Ultrasound, and biopsy in some cases if possible (Depends on the patients and their financial issues).

No interventions assigned to this group

Chronic Liver Diseases (group 2)

This group will be including 31 patients, and the diagnoses will be based on laboratory such as (liver function tests, viral markers, AFP,) and by ultrasound findings (shrunken liver, coarse echo-pattern, attenuated hepatic vein and finding nodular surface)

No interventions assigned to this group

Healthy Volunteer (group 3)

It will include 32 subjects that serve as control group.

These all patients and control groups will be subject the following parameters: Biochemical tests such as (Liver function tests, viral markers, serum AFP, CBC, Kidney functions and others) and circulating MicroRNAs levels of all these subjects.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of HCC patients through history taking and physical Examination, AFP and ultrasonography (> 5cm in size).
• Chronic liver disease patients with history of liver disease rather than HCC such as cirrhosis, chronic viral hepatitis, non-alcoholic liver disease (NALD).
• Healthy volunteers with no history of liver problems.
• Informed consent from all participants before enrollment in the study.

Exclusion Criteria

• HCC less than 5 cm in size during ultrasound examinations
• Extrahepatic disease, other primary tumour
• Inability to provide informed consent or who refused to draw off blood.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

People's Friendship University of Russia

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdulkadir Hassan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel P Ogurtsov, MD

Role: STUDY_CHAIR

People's Friendship University of Russia

Mohamed A Hassan

Role: PRINCIPAL_INVESTIGATOR

RUDN University, Abrar University

Central Contacts

Mohamed A Hassan

Role: CONTACT

kadlesom@gmail.com

+79998499389

Aleksandr A Abramov

Role: CONTACT

Other Identifiers

1072178049

Identifier Type: -

Identifier Source: org_study_id