<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227510</url>
  </required_header>
  <id_info>
    <org_study_id>1072178049</org_study_id>
    <nct_id>NCT03227510</nct_id>
  </id_info>
  <brief_title>MicroRNAs as Diagnostic Biomarkers in Hepatocellular Carcinoma Among Somali Patients</brief_title>
  <official_title>Circulating MicroRNAs as Biomarkers in Hepatocellular Carcinoma Among Somali Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>People's Friendship University of Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>People's Friendship University of Russia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third&#xD;
      leading cause of cancer that related death in the worldwide. Although, current most of&#xD;
      doctors and laboratorians of HCC diagnoses bases are medical imaging such ultrasound, MRI,&#xD;
      CT-scan and laboratory analyses tests for serum tumor markers such as alpha-fetoprotein (AFP)&#xD;
      which characterized by very low of sensitivity in the detection of HCC. Last two decades,&#xD;
      scientists was focused researches of small molecules called MicroRNAs which are produced by&#xD;
      human cells and can be released in the blood.&#xD;
&#xD;
      MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging&#xD;
      non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and&#xD;
      to predict prognosis. A number of studies exposed an abnormal expression of human serum&#xD;
      MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently,&#xD;
      MicroRNAs have a role in the development of HCC, but still it is unknown if these small&#xD;
      molecules will be used as biomarker for diagnosis and survival of HCC.&#xD;
&#xD;
      The aim of this study is to establish MicroRNAs as biomarkers for diagnostic tool of HCC&#xD;
      patients and to compare to circulating levels of MicroRNAs in chronic liver diseases patients&#xD;
      and health volunteers and those HCC patients and To determine the clinical utility of&#xD;
      MicroRNAs as a diagnostic maker of hepatocellular carcinoma comparing with alpha fetoprotein&#xD;
      the current marker of (HCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) is the most common primary liver cancer and is the third&#xD;
      leading cause of cancer that related death in the worldwide. According the burden of cancer&#xD;
      in economically developing countries is increasing in a result of population aging and growth&#xD;
      in addition to increasing the adaptation of cancer-related lifestyle choices such as physical&#xD;
      inactivates, smoking and western diets. Liver cancer in women are seventh most common&#xD;
      diagnosed cancer and sixth most cause of cancer death while in men are fifth diagnosed cancer&#xD;
      and second cause of cancer death. In 2008 liver cancer new cases were estimated 748,300 and&#xD;
      death cases were 695,900 occurred in worldwide. Viral hepatitis infections, alcohol, fungal&#xD;
      toxins (aflatoxins), food additives, toxins produced industrial chemicals and water and air&#xD;
      pollutants are the major factors of primary liver cancer.&#xD;
&#xD;
      Although, current most of doctors and laboratorians of HCC diagnoses bases are medical&#xD;
      imaging such ultrasound, MRI, CT-scan and laboratory analyses tests for serum tumor markers&#xD;
      such as alpha-fetoprotein (AFP) which characterized by very low of sensitivity in the&#xD;
      detection of HCC. Last two decades, scientists was focused researches of small molecules&#xD;
      called MicroRNAs which are produced by human cells and can be released in the blood.&#xD;
&#xD;
      MicroRNAs are class of (20 - 25 nucleotide in length) non-coding RNAs, and its emerging&#xD;
      non-invasive diagnostic biomarker for cancer diagnosing, screening, monitoring treatment and&#xD;
      to predict prognosis. A number of studies exposed an abnormal expression of human serum&#xD;
      MicroRNAs in many tumors such as liver, pancreatic and colorectal carcinoma. Recently,&#xD;
      MicroRNAs have a role in the development of HCC, but still it is unknown if these small&#xD;
      molecules will be used as biomarker for diagnosis and survival of HCC.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
        1. To recognize serum microRNAs as a diagnosis or prediction biomarker for Hepatocellular&#xD;
           carcinoma.&#xD;
&#xD;
        2. To correlate with the expression level of microRNAs between HCC patients , chronic liver&#xD;
           disease and health volunteer subjects.&#xD;
&#xD;
        3. To determine the clinical utility of MicroRNAs as a diagnostic maker of Hepatocellular&#xD;
           carcinoma comparing with alpha fetoprotein the current marker of (HCC).&#xD;
&#xD;
      Methods Study design: This is observational study (Case Control Study). A total of 126&#xD;
      subjects aged over 18 years old; that divided into three groups will be enrolled in this&#xD;
      study in Dufle Specialist Hospital; these groups are HCC group, Chronic liver disease group&#xD;
      and health volunteer group. The diagnosed criteria of HCC group are ultrasound which its&#xD;
      nodules more than 5cm, liver function tests, viral markers and AFP. The other groups (chronic&#xD;
      liver disease and health) the diagnoses will be based on laboratory such as (liver function&#xD;
      tests, viral markers, AFP, complete blood count (CBC), Kidney functions and others) the&#xD;
      clinical and laboratory analysis data will be collected perceptively The blood samples will&#xD;
      be collected at one time, after that the blood samples will be separated using&#xD;
      Serum-separating tubes and then centrifuges to get the serum and will be stored in -20°C&#xD;
      before transferred from Somalia to Russia.&#xD;
&#xD;
      Viral marker Hepatitis B surface antigen (HBsAg) and antibody to HCV (anti-HCV) will be&#xD;
      checked using commercially available enzyme linked immunosorbent assay kits for every subject&#xD;
      of these three groups.&#xD;
&#xD;
      The expression of MicroRNAs will be detected by quantitative reverse-transcriptase polymerase&#xD;
      chain reaction (qRT-PCR) with human TaqMan MicroRNA Assay Kits (Applied Biosystems) of these&#xD;
      groups either HCC group , Chronic liver disease and healthy volunteers. The investigators&#xD;
      will define the groups of HCC, Chronic liver disease and healthy volunteers with high or low&#xD;
      expression based on the median expression value of each microRNA.&#xD;
&#xD;
      All statistical analyses will be carried out with Statistical Package for the Social Sciences&#xD;
      (SPSS) version 20. MicroRNAs expressions among different group (HCC, Chronic liver diseases,&#xD;
      and healthy volunteers) will be analyzed by SPSS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MicroRNAs and its Correlation to Development and prediction of HCC</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCC Cases (Group 1)</arm_group_label>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Liver Diseases (group 2)</arm_group_label>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteer (group 3)</arm_group_label>
    <description>It will include 32 subjects that serve as control group.&#xD;
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.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample from patients with HCC and from chronic liver disease and healthy volunteer&#xD;
      controls&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population will be carried out on 126 subjects who will be admitting from the&#xD;
        outpatient clinic of Dufle Specialist Hospital Mogadishu, Somalia.&#xD;
&#xD;
        They will be classified into 3 groups:&#xD;
&#xD;
        Group I: It will include 63 HCC subjects. Group II: It will include 31 chronic liver&#xD;
        disease patients. Group III: It will include 32 healthy volunteer subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of HCC patients through history taking and physical Examination,&#xD;
             AFP and ultrasonography (&gt; 5cm in size).&#xD;
&#xD;
          -  Chronic liver disease patients with history of liver disease rather than HCC such as&#xD;
             cirrhosis, chronic viral hepatitis, non-alcoholic liver disease (NALD).&#xD;
&#xD;
          -  Healthy volunteers with no history of liver problems.&#xD;
&#xD;
          -  Informed consent from all participants before enrollment in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HCC less than 5 cm in size during ultrasound examinations&#xD;
&#xD;
          -  Extrahepatic disease, other primary tumour&#xD;
&#xD;
          -  Inability to provide informed consent or who refused to draw off blood.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pavel P Ogurtsov, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RUDN University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed A Hassan</last_name>
    <role>Principal Investigator</role>
    <affiliation>RUDN University, Abrar University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed A Hassan</last_name>
    <phone>+79998499389</phone>
    <email>kadlesom@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aleksandr A Abramov</last_name>
  </overall_contact_backup>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>People's Friendship University of Russia</investigator_affiliation>
    <investigator_full_name>Mohamed Abdulkadir Hassan</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma , MicroRNAs, Somalia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227510
org study id: 1072178049
nct id: NCT03227510
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: MicroRNAs and its Correlation to Development and prediction of HCC
time frame: 6 months to 1 year
description: Circulating MicroRNAs levels in serum samples from HCC, Chronic liver diseases and health volunteers Somali subjects.
arm group label: HCC Cases (Group 1)
description: 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).
arm group label: Chronic Liver Diseases (group 2)
description: 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)
arm group label: Healthy Volunteer (group 3)
description: 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.
blood sample from patients with HCC and from chronic liver disease and healthy volunteer
      controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pavel P Ogurtsov, MD
role: Study Chair
affiliation: RUDN University
last name: Mohamed A Hassan
role: Principal Investigator
affiliation: RUDN University, Abrar University
last name: Mohamed A Hassan
phone: +79998499389
email: kadlesom@gmail.com
last name: Aleksandr A Abramov
responsible party type: Principal Investigator
investigator affiliation: People's Friendship University of Russia
investigator full name: Mohamed Abdulkadir Hassan
investigator title: MD
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No