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/NCT06030895</url>
    </required_header>
    <id_info>
      <org_study_id>sorafenib In Egyptian Patients</org_study_id>
      <nct_id>NCT06030895</nct_id>
    </id_info>
    <brief_title>Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.</brief_title>
    <official_title>Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Damanhour University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mransoura University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Damanhour University</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>
        This study aims to determine the predictive effect of ATG10 and IL6 genetic polymorphisms in&#xD;
        safety and efficacy of sorafenib used for the treatment of Egyptian HCC patients. Moreover,&#xD;
        this study will determine the association between genetic polymorphisms of ATG10 and IL6 with&#xD;
        HCC severity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective pharmcogentic study for Egyptian HCC patients treating with oral sorafenib.&#xD;
  &#xD;
          1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,&#xD;
             Damanhour University.&#xD;
  &#xD;
          2. 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice&#xD;
             daily) or (200mg twice daily),. will be recruited from Mansoura University Hospital,&#xD;
             Mansoura, Egypt.&#xD;
  &#xD;
          3. At baseline and follow up visits after Sorafenib, all patients will be assessed for&#xD;
             complete blood count (CBC), kidney function, liver function, liver enzymes, alpha&#xD;
             fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be&#xD;
             performed .&#xD;
  &#xD;
          4. Blood samples will be collected for ATG10 AND IL6 genotyping.&#xD;
  &#xD;
          5. Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain&#xD;
             reaction (RT-PCR).&#xD;
  &#xD;
               -  Five mls of whole blood will be collected&#xD;
  &#xD;
               -  Extraction of genomic DNA from blood samples by DNA extraction kit.&#xD;
  &#xD;
               -  DNA qualification will be performed by Nano drop.&#xD;
  &#xD;
               -  Genotyping will be done by allelic discrimination using Taqman assays specific for&#xD;
                  each polymorphism.&#xD;
  &#xD;
               -  Assays will be done according to manufacturer protocol using real time PCR machine.&#xD;
  &#xD;
          6. Appropriate statistical tests will be conducted to evaluate the significance of the&#xD;
             results.&#xD;
  &#xD;
          7. Results, conclusion, discussion and recommendations will be given. Ethical Issue&#xD;
  &#xD;
               -  Informed consent will be signed by all eligible patients before enrolling in the&#xD;
                  study.&#xD;
  &#xD;
               -  All patients' data will be confidential.&#xD;
  &#xD;
        Efficacy and Safety outcomes:&#xD;
  &#xD;
          1. Target lesions response will be measured according to modified Response Evaluation&#xD;
             Criteria in Solid Tumors (mRECIST) Complete response, Partial response, Progressive&#xD;
             disease and Stable disease.&#xD;
  &#xD;
          2. The appropriate dose of sorafenib will be determined individually based on the patient&#xD;
             tolerability.&#xD;
  &#xD;
          3. Follow up will be performed for detection of tumor size using triphasic CT scan as a&#xD;
             measure of efficacy. Moreover, all patients will be reevaluated for CBC,AFP, liver and&#xD;
             kidney functions, in the follow up visit, to detect incidence of any adverse effects.&#xD;
  &#xD;
          4. Patients will be asked for any side effects such as (diarrhea, anorexia, nausea,&#xD;
             vomiting).&#xD;
  &#xD;
          5. Patients will be followed for progression-free survival after receiving soarfenib.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 12, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>100 hepatocellular carcinoma patients</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ATG10 genotyping</measure>
      <time_frame>6 months</time_frame>
      <description>Gene polymorphism</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IL6 genotyping</measure>
      <time_frame>6 months</time_frame>
      <description>Gene polymorphism</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety Outcomes</measure>
      <time_frame>6 months</time_frame>
      <description>Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Sorafenib group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice daily) or (200mg twice daily), will be recruited from Mansoura University Hospital, Mansoura, Egypt.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sorafenib Tablets</intervention_name>
      <description>Sorafenib Tablets (200 -400 mg) twice daily</description>
      <arm_group_label>Sorafenib group</arm_group_label>
      <other_name>Nexavar</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. A diagnosed HCC patient.&#xD;
  &#xD;
            2. Child-pugh class A.&#xD;
  &#xD;
            3. Performance status 1-2 (ECOG scale)&#xD;
  &#xD;
            4. Laboratory investigation : Hemoglobin ≥8.5 mg\dl, INR ≤2.3 ,Albumin≥2.8g\dl, ALT and&#xD;
               AST ≤ 3 times the ULN&#xD;
  &#xD;
            5. Age ≥20 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients refused to sign the written consent.&#xD;
  &#xD;
            2. Age &gt; 75 years.&#xD;
  &#xD;
            3. Renal failure requiring hemo- or peritoneal dialysis&#xD;
  &#xD;
            4. History of cardiac disease&#xD;
  &#xD;
            5. Active clinically serious infections&#xD;
  &#xD;
            6. Known history of human immunodeficiency virus (HIV) infection&#xD;
  &#xD;
            7. Pregnant female&#xD;
  &#xD;
            8. Child-pugh class B and C.&#xD;
  &#xD;
            9. Performance status 3 or 4.&#xD;
  &#xD;
           10. Patient who are indicated for surgical resection or liver transplant (MDT).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rehab H Werida, Ass. Prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Damanhour University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Noha El bassiouny, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Damanhour University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rehab H Werida, Ass. Prof.</last_name>
      <phone>+201005359968</phone>
      <email>rehabwrieda@pharm.dmu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Asmaa Elsheshtawy, Bachlor</last_name>
      <email>a.elsheshtawy00043@pharm.dmu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mansoura University Hospital</name>
        <address>
          <city>Mansoura</city>
          <state>El-Dakahelia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rehab H Werida, Ass. Prof.</last_name>
        <phone>+201005359968</phone>
        <email>rehabwrieda@pharm.dmu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Monir H. Bahgat., Prof.</last_name>
        <email>a.elsheshtawy00043@pharm.dmu.edu.eg</email>
      </contact_backup>
      <investigator>
        <last_name>Asmaa Elsheshtawy, bachelor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Damanhour University</investigator_affiliation>
      <investigator_full_name>Rehab Werida</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>ATG10</keyword>
    <keyword>IL6</keyword>
    <keyword>Genotyping</keyword>
    <keyword>Safety</keyword>
    <keyword>Efficacy</keyword>
    <keyword>Polymorphism</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sorafenib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06030895
  org study id: sorafenib In Egyptian Patients
  nct id: NCT06030895
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to determine the predictive effect of ATG10 and IL6 genetic polymorphisms in
        safety and efficacy of sorafenib used for the treatment of Egyptian HCC patients. Moreover,
        this study will determine the association between genetic polymorphisms of ATG10 and IL6 with
        HCC severity.
  A prospective pharmcogentic study for Egyptian HCC patients treating with oral sorafenib.
  
          1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,
             Damanhour University.
  
          2. 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice
             daily) or (200mg twice daily),. will be recruited from Mansoura University Hospital,
             Mansoura, Egypt.
  
          3. At baseline and follow up visits after Sorafenib, all patients will be assessed for
             complete blood count (CBC), kidney function, liver function, liver enzymes, alpha
             fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be
             performed .
  
          4. Blood samples will be collected for ATG10 AND IL6 genotyping.
  
          5. Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain
             reaction (RT-PCR).
  
               -  Five mls of whole blood will be collected
  
               -  Extraction of genomic DNA from blood samples by DNA extraction kit.
  
               -  DNA qualification will be performed by Nano drop.
  
               -  Genotyping will be done by allelic discrimination using Taqman assays specific for
                  each polymorphism.
  
               -  Assays will be done according to manufacturer protocol using real time PCR machine.
  
          6. Appropriate statistical tests will be conducted to evaluate the significance of the
             results.
  
          7. Results, conclusion, discussion and recommendations will be given. Ethical Issue
  
               -  Informed consent will be signed by all eligible patients before enrolling in the
                  study.
  
               -  All patients' data will be confidential.
  
        Efficacy and Safety outcomes:
  
          1. Target lesions response will be measured according to modified Response Evaluation
             Criteria in Solid Tumors (mRECIST) Complete response, Partial response, Progressive
             disease and Stable disease.
  
          2. The appropriate dose of sorafenib will be determined individually based on the patient
             tolerability.
  
          3. Follow up will be performed for detection of tumor size using triphasic CT scan as a
             measure of efficacy. Moreover, all patients will be reevaluated for CBC,AFP, liver and
             kidney functions, in the follow up visit, to detect incidence of any adverse effects.
  
          4. Patients will be asked for any side effects such as (diarrhea, anorexia, nausea,
             vomiting).
  
          5. Patients will be followed for progression-free survival after receiving soarfenib.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: 100 hepatocellular carcinoma patients
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ATG10 genotyping
  time frame: 6 months
  description: Gene polymorphism
  measure: IL6 genotyping
  time frame: 6 months
  description: Gene polymorphism
  measure: Safety Outcomes
  time frame: 6 months
  description: Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting
  arm group label: Sorafenib group
  arm group type: Experimental
  description: 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice daily) or (200mg twice daily), will be recruited from Mansoura University Hospital, Mansoura, Egypt.
  intervention type: Drug
  intervention name: Sorafenib Tablets
  description: Sorafenib Tablets (200 -400 mg) twice daily
  arm group label: Sorafenib group
  other name: Nexavar
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Rehab H Werida, Ass. Prof.
  role: Study Chair
  affiliation: Damanhour University
  last name: Noha El bassiouny, Lecturer
  role: Study Director
  affiliation: Damanhour University
  last name: Rehab H Werida, Ass. Prof.
  phone: +201005359968
  email: rehabwrieda@pharm.dmu.edu.eg
  last name: Asmaa Elsheshtawy, Bachlor
  email: a.elsheshtawy00043@pharm.dmu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Damanhour University
  investigator full name: Rehab Werida
  investigator title: Associate Professor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  mesh term: Sorafenib
  sharing ipd: No