<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/NCT03039322</url>
  </required_header>
  <id_info>
    <org_study_id>914</org_study_id>
    <nct_id>NCT03039322</nct_id>
  </id_info>
  <brief_title>Golgi Protein for HCC Diagnosis</brief_title>
  <official_title>Golgi Protein 73 for Diagnosis of HCC in Egyptian Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      This case-control study was conducted on 90 patients who were equally divided into two&#xD;
      groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical&#xD;
      or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed&#xD;
      to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using&#xD;
      ELISA technique&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2014</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</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>Golgi protein correlated with presence of HCC</measure>
    <time_frame>within one year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Screening for Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCC</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>liver cirrhosis No HCC</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum Golgi Protein 73</intervention_name>
    <description>Serum test</description>
    <arm_group_label>HCC</arm_group_label>
    <arm_group_label>liver cirrhosis No HCC</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group I: Included 45 patients with liver cirrhosis due to HCV infection. Liver cirrhosis&#xD;
        was diagnosed clinically, laboratory, and radiologically. Chronic HCV infection was&#xD;
        diagnosed by positive HCV antibody and positive quantitative HCV PCR.&#xD;
&#xD;
        Group II: Included 45 patients with Hepatocellular carcinoma (HCC) on top of HCV cirrhosis&#xD;
        diagnosed by two imaging modalities, abdominal ultrasound and the characteristic arterial&#xD;
        enhancement and venous washout in Tri-phasic CT abdomen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients were older than 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with hepatic focal lesions not due to HCC such as Hemangioma, Hepatic cyst,&#xD;
             and liver metastases; patients infected with HIV; patients with any autoimmune&#xD;
             disease; or patients with metastatic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Shereen Abou Bakr Saleh</investigator_full_name>
    <investigator_title>Assisstant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- 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/NCT03039322
org study id: 914
nct id: NCT03039322
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This case-control study was conducted on 90 patients who were equally divided into two
      groups. Group 1 included 45 patients with HCV-related chronic liver disease without clinical
      or radiological evidence of HCC (control group), and Group 2 included 45 patients diagnosed
      to have HCC by Triphasic abdominal CT (patient group). Serum AFP and GP73 were measured using
      ELISA technique
observational model: Case-Control
time perspective: Cross-Sectional
measure: Golgi protein correlated with presence of HCC
time frame: within one year
arm group label: HCC
arm group label: liver cirrhosis No HCC
intervention type: Diagnostic Test
intervention name: Serum Golgi Protein 73
description: Serum test
arm group label: HCC
arm group label: liver cirrhosis No HCC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Shereen Abou Bakr Saleh
investigator title: Assisstant Professor
mesh term: Carcinoma, Hepatocellular