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/NCT05967429</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-07PD</org_study_id>
      <nct_id>NCT05967429</nct_id>
    </id_info>
    <brief_title>Predictors of Sorafenib Response in HCC</brief_title>
    <official_title>Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        Evaluating the nutrition status of patients with advanced HCC who received sorafenib.&#xD;
  &#xD;
        Using the pretreatment nutrition status and quality of life as predictors to sorafenib&#xD;
        response&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were&#xD;
        gathered from medical records, including&#xD;
  &#xD;
        age sex body weight and height (BMI) pre-therapy laboratory counts of white cells,&#xD;
        neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin&#xD;
        concentration, AST, ALT, AFP, PT and CONC&#xD;
  &#xD;
        Barcelona Clinic Liver Cancer Stage (BCLC) of all patients&#xD;
  &#xD;
        The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by&#xD;
        the lymphocyte count.&#xD;
  &#xD;
        The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the&#xD;
        lymphocyte count.&#xD;
  &#xD;
        Weight loss difference after treatment Portal hypertension was defined as presence of either&#xD;
        collaterals on radiological examination, esophageal varices by upper gastrointestinal&#xD;
        endoscopy and/or thrombocytopenia.&#xD;
  &#xD;
        Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8)&#xD;
        Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>assessment of nutrition status</measure>
      <time_frame>Augest 2023 to March 2024</time_frame>
      <description>Prognostic nutrition index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predictors of sorafenib response</measure>
      <time_frame>Augest 2023 to March 2024</time_frame>
      <description>The neutrophil-to- lymphocyte ratio</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assess the quality of life</measure>
      <time_frame>Augest 2023 to March 2024</time_frame>
      <description>using FACT Hepatobiliary Symptom Index</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Hepatocellular carcinoma receiving sorafenib</arm_group_label>
      <description>Patient with advanced stage HCC receiving sorafenib</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The neutrophil-to- lymphocyte ratio</intervention_name>
      <description>It was calculated by dividing the neutrophil count by the lymphocyte count.</description>
      <arm_group_label>Hepatocellular carcinoma receiving sorafenib</arm_group_label>
      <other_name>NLR</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Prognostic nutrition index</intervention_name>
      <description>It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL</description>
      <arm_group_label>Hepatocellular carcinoma receiving sorafenib</arm_group_label>
      <other_name>PNI</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Hepatocellular carcinoma patient receiving sorafenib&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HCC recieved sorafenib&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refuse to participate&#xD;
  &#xD;
            -  Patients recieving other treatment modalities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Amr Zagloul, MD</last_name>
      <role>Study Director</role>
      <affiliation>Sohag University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed othman, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Sohag University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rafat Abd El Aal, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Sohag University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mona Abdelrahmam, MD</last_name>
      <phone>01021025895</phone>
      <email>monamohamed@med.sohag.edu.eg</email>
    </overall_contact>
    <reference>
      <citation>Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23.</citation>
      <PMID>32335238</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Mona Mohammed Abdelrhman</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Nutrition assessment</keyword>
    <keyword>HCC</keyword>
    <keyword>Sorafenib</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>
  
  
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/NCT05967429
  org study id: Soh-Med-23-07-07PD
  nct id: NCT05967429
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluating the nutrition status of patients with advanced HCC who received sorafenib.
  
        Using the pretreatment nutrition status and quality of life as predictors to sorafenib
        response
  This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were
        gathered from medical records, including
  
        age sex body weight and height (BMI) pre-therapy laboratory counts of white cells,
        neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin
        concentration, AST, ALT, AFP, PT and CONC
  
        Barcelona Clinic Liver Cancer Stage (BCLC) of all patients
  
        The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by
        the lymphocyte count.
  
        The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the
        lymphocyte count.
  
        Weight loss difference after treatment Portal hypertension was defined as presence of either
        collaterals on radiological examination, esophageal varices by upper gastrointestinal
        endoscopy and/or thrombocytopenia.
  
        Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8)
        Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.
  observational model: Case-Only
  time perspective: Prospective
  measure: assessment of nutrition status
  time frame: Augest 2023 to March 2024
  description: Prognostic nutrition index
  measure: Predictors of sorafenib response
  time frame: Augest 2023 to March 2024
  description: The neutrophil-to- lymphocyte ratio
  measure: Assess the quality of life
  time frame: Augest 2023 to March 2024
  description: using FACT Hepatobiliary Symptom Index
  arm group label: Hepatocellular carcinoma receiving sorafenib
  description: Patient with advanced stage HCC receiving sorafenib
  intervention type: Diagnostic Test
  intervention name: The neutrophil-to- lymphocyte ratio
  description: It was calculated by dividing the neutrophil count by the lymphocyte count.
  arm group label: Hepatocellular carcinoma receiving sorafenib
  other name: NLR
  intervention type: Diagnostic Test
  intervention name: Prognostic nutrition index
  description: It was calculated using the following formula: serum albumin (g/L) + 0.005 × total lymphocyte count/μL
  arm group label: Hepatocellular carcinoma receiving sorafenib
  other name: PNI
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Amr Zagloul, MD
  role: Study Director
  affiliation: Sohag University
  last name: Ahmed othman, MD
  role: Study Chair
  affiliation: Sohag University
  last name: Rafat Abd El Aal, MD
  role: Study Chair
  affiliation: Sohag University
  last name: Mona Abdelrahmam, MD
  phone: 01021025895
  email: monamohamed@med.sohag.edu.eg
  citation: Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23.
  PMID: 32335238
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mona Mohammed Abdelrhman
  investigator title: Principal investigator
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: No