MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients

NCT03227510 | Unknown

• 1 other identifier: 1072178049
• Study Type: observational
• Target: 126
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma , MicroRNAs, Somalia

Outcome Measures

Primary Outcomes (1)

• MicroRNAs and its Correlation to Development and prediction of HCC

  Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.

  6 months to 1 year

Study Arms (3)

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).

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)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be carried out on 126 subjects who will be admitting from the outpatient clinic of Dufle Specialist Hospital Mogadishu, Somalia. They will be classified into 3 groups: Group I: It will include 63 HCC subjects. Group II: It will include 31 chronic liver disease patients. Group III: It will include 32 healthy volunteer subjects

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• People's Friendship University of Russia: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample from patients with HCC and from chronic liver disease and healthy volunteer controls

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Pavel P Ogurtsov, MD

  People's Friendship University of Russia

  STUDY CHAIR

• Mohamed A Hassan

  RUDN University, Abrar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Hassan

CONTACT

+79998499389; kadlesom@gmail.com

Aleksandr A Abramov

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: November 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share