MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients

July 22, 2017 updated by: Mohamed Abdulkadir Hassan, People's Friendship University of Russia

Circulating MicroRNAs as Biomarkers in Hepatocellular Carcinoma Among Somali Patients

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Aleksandr A Abramov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MicroRNAs and its Correlation to Development and prediction of HCC
Time Frame: 6 months to 1 year
Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.
6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
People's Friendship University of Russia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pavel P Ogurtsov, MD, RUDN University
  • Principal Investigator: Mohamed A Hassan, RUDN University, Abrar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1072178049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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