xml: <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/NCT06023745</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-04-11PD</org_study_id>
      <nct_id>NCT06023745</nct_id>
    </id_info>
    <brief_title>Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.</brief_title>
    <official_title>Study IL- 35 Level and Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480) Gene Variations in Chronic Hepatitis B.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \ Irsin&#xD;
        (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the&#xD;
        distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis&#xD;
        B group.&#xD;
  &#xD;
          -  Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B.&#xD;
  &#xD;
          -  Asses the correlation between SOD serum level and the risk of chronic hepatitis B.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hepatitis B virus (HBV) infection is a serious public health problem worldwide, with&#xD;
        approximately 2 billion people having a history of HBV infection and 350 million of them&#xD;
        suffering from chronic HBV infection (1).&#xD;
  &#xD;
        Although the host factors (such as infection age, gender and immune status), viral and&#xD;
        environmental factors are thought to be involved in affecting the development of CHB. The&#xD;
        mechanisms underlying the different clinical outcomes of HBV infection have not been fully&#xD;
        understood. Studies indicated that host genetic factors play a critical role in the&#xD;
        development of HBV infection, especially single nucleotide polymorphisms (SNPs), is regarded&#xD;
        to be one of the determinants for this clinical heterogeneity(2,3). Some polymorphisms have&#xD;
        been reported to be involved in susceptibility to CHB in disease severity and progression, or&#xD;
        disease prognosis (4,5).&#xD;
  &#xD;
        Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some&#xD;
        proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a&#xD;
        transcriptional co-activator which does not bind directly to DNA. Studies indicated that the&#xD;
        estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding&#xD;
        to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two&#xD;
        domains. One of them allows the interaction with DNA, and the second one with a ligand. The&#xD;
        ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor&#xD;
        does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen&#xD;
        response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA&#xD;
        elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of&#xD;
        genes such as FNDC5 (6).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480)</measure>
      <time_frame>2 months</time_frame>
      <description>study gene polymorphism of irsin in chronic hepatitis b patients</description>
    </primary_outcome>
    <primary_outcome>
      <measure>measure of il 35 in serum</measure>
      <time_frame>2 months</time_frame>
      <description>il 35 level in serum of chronic hepatitis b pTIENTS</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hepatitis B, Chronic</condition>
    <arm_group>
      <arm_group_label>case</arm_group_label>
      <description>30 patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <description>healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>genotyping</intervention_name>
      <description>Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.</description>
      <arm_group_label>case</arm_group_label>
      <arm_group_label>control</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        blood samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          This study will be conducted on 50 patients 30 patients diagnosed as a clinical disease of&#xD;
          CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA&#xD;
          level, biochemical liver function, and ultrasonography (15) A control group of 30 healthy&#xD;
          volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities&#xD;
          based on physical examination&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients diagnosed as a clinical disease of CHB according to the diagnostic criteria&#xD;
               of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function,&#xD;
               and ultrasonography&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The chronic HBV patients on antiviral therapy will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Shimaa Badawy Hemdan, lecturer</last_name>
      <phone>01115894759</phone>
      <email>shimaabadwy@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shimaa badawy Hemdan, lecturer</last_name>
      <phone>01003079646</phone>
      <email>shimaabadwy@med.sohag.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Eskandari E, Metanat M, Pahlevani E, Nakhzari-Khodakheir T. Association between TGFbeta1 polymorphisms and chronic hepatitis B infection in an Iranian population. Rev Soc Bras Med Trop. 2017 May-Jun;50(3):301-308. doi: 10.1590/0037-8682-0266-2016.</citation>
      <PMID>28700046</PMID>
    </reference>
    <reference>
      <citation>Blackburn EH. Telomeres and telomerase: the means to the end (Nobel lecture). Angew Chem Int Ed Engl. 2010 Oct 4;49(41):7405-21. doi: 10.1002/anie.201002387. No abstract available.</citation>
      <PMID>20821774</PMID>
    </reference>
    <reference>
      <citation>Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.</citation>
      <PMID>36430689</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Shimaa Badway Hemdan</investigator_full_name>
      <investigator_title>lecturer of medical biochemistry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis B</mesh_term>
      <mesh_term>Hepatitis B, Chronic</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023745
  org study id: Soh-Med-23-04-11PD
  nct id: NCT06023745
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \ Irsin
        (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the
        distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis
        B group.
  
          -  Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B.
  
          -  Asses the correlation between SOD serum level and the risk of chronic hepatitis B.
  Hepatitis B virus (HBV) infection is a serious public health problem worldwide, with
        approximately 2 billion people having a history of HBV infection and 350 million of them
        suffering from chronic HBV infection (1).
  
        Although the host factors (such as infection age, gender and immune status), viral and
        environmental factors are thought to be involved in affecting the development of CHB. The
        mechanisms underlying the different clinical outcomes of HBV infection have not been fully
        understood. Studies indicated that host genetic factors play a critical role in the
        development of HBV infection, especially single nucleotide polymorphisms (SNPs), is regarded
        to be one of the determinants for this clinical heterogeneity(2,3). Some polymorphisms have
        been reported to be involved in susceptibility to CHB in disease severity and progression, or
        disease prognosis (4,5).
  
        Irisin is encoded by the FNDC5 gene, whose expression is controlled by the peroxi- some
        proliferator activated receptor gamma coactivator 1 alpha (PGC-1α). PGC-1α is a
        transcriptional co-activator which does not bind directly to DNA. Studies indicated that the
        estrogen-related receptor alpha (ERRα) could be a factor that plays a role in PGC-1α binding
        to DNA. ERRα is encoded by the ESRRA gene and is an orphan nuclear receptor, which has two
        domains. One of them allows the interaction with DNA, and the second one with a ligand. The
        ERRα structure is similar to that of the estrogen receptor alpha (ERα), but this receptor
        does not bind to natural estrogens. ERRα interacts with a canonical sequence of the estrogen
        response elements (ERRE). ERRα and ERα could compete with each other to bind to similar DNA
        elements. Together, ERRα binds to DNA, in complex with PGC-1α, to regulate the activity of
        genes such as FNDC5 (6).
  observational model: Case-Control
  time perspective: Retrospective
  measure: genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480)
  time frame: 2 months
  description: study gene polymorphism of irsin in chronic hepatitis b patients
  measure: measure of il 35 in serum
  time frame: 2 months
  description: il 35 level in serum of chronic hepatitis b pTIENTS
  arm group label: case
  description: 30 patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography
  arm group label: control
  description: healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination
  intervention type: Genetic
  intervention name: genotyping
  description: Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.
  arm group label: case
  arm group label: control
  blood samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  last name: Shimaa Badawy Hemdan, lecturer
  phone: 01115894759
  email: shimaabadwy@med.sohag.edu.eg
  last name: Shimaa badawy Hemdan, lecturer
  phone: 01003079646
  email: shimaabadwy@med.sohag.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Eskandari E, Metanat M, Pahlevani E, Nakhzari-Khodakheir T. Association between TGFbeta1 polymorphisms and chronic hepatitis B infection in an Iranian population. Rev Soc Bras Med Trop. 2017 May-Jun;50(3):301-308. doi: 10.1590/0037-8682-0266-2016.
  PMID: 28700046
  citation: Blackburn EH. Telomeres and telomerase: the means to the end (Nobel lecture). Angew Chem Int Ed Engl. 2010 Oct 4;49(41):7405-21. doi: 10.1002/anie.201002387. No abstract available.
  PMID: 20821774
  citation: Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.
  PMID: 36430689
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Shimaa Badway Hemdan
  investigator title: lecturer of medical biochemistry
  mesh term: Hepatitis A
  mesh term: Hepatitis B
  mesh term: Hepatitis B, Chronic
  mesh term: Hepatitis
  sharing ipd: Undecided