<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/NCT04412161</url>
  </required_header>
  <id_info>
    <org_study_id>GGT-HCC-6CM</org_study_id>
    <nct_id>NCT04412161</nct_id>
  </id_info>
  <brief_title>Liver Transplant for Larger Hepatocellular Carcinoma in Malatya: The Role of GGT and AFP</brief_title>
  <official_title>Retrospective Cohort Study-Analysis of LT Patients With HCC (Maximum Tumor Diameter &gt; 6 cm).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
      Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with&#xD;
      &gt;6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP &lt;200 ng/ml&#xD;
      and GGT &lt;104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in&#xD;
      patient prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:A retrospective analysis was performed of prospectively-collected transplant data&#xD;
      on outcomes of patients with large size HCCs,to examine possible prognostically-useful&#xD;
      factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were&#xD;
      identified. Their survival and full clinical characteristics were examined, with respect to&#xD;
      serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT&#xD;
      104 IU/ml were identified and used in this study. Significantly longer overall-survival and&#xD;
      disease-free-survival were found for patients who had lower values of either parameter,&#xD;
      compared with higher values.Even greater differences in survival were found when the 2&#xD;
      parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most&#xD;
      consistent clinical correlates for these longer survivals were degree of tumor&#xD;
      differentiation and absence of microscopic portal venous invasion.Two tumor size bands were&#xD;
      identified,to search for the limits of this approach with larger tumors, namely 6-10 and&#xD;
      &gt;10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients&#xD;
      with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low&#xD;
      GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic&#xD;
      identifier for patients with large size HCCs being treated by liver transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2006</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall and disease free survivals</measure>
    <time_frame>five years follow up</time_frame>
    <description>to analyse the factors that effect the survivals</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Liver Transplant Disorder</condition>
  <arm_group>
    <arm_group_label>Extra-Malatya</arm_group_label>
    <description>Liver transplant patients with MTD&gt;6 cm of HCC</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver transplantation</intervention_name>
    <description>Living donor liver transplantation</description>
    <arm_group_label>Extra-Malatya</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular&#xD;
        carcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver transplant patients with maximum tumor diameter greater than 6 cm of&#xD;
             hepatocellular carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Early postoperative mortality (within 90 days)&#xD;
&#xD;
          -  Advanced stage tumors (explant patology revealed that tumor continues in the surgical&#xD;
             cite such as positive lymph node metastases, macroscopic portal vein trombosis,&#xD;
             diaphragmatic invasion, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Volkan Ince</investigator_full_name>
    <investigator_title>MD, FEBS, Assoc.Prof</investigator_title>
  </responsible_party>
  <keyword>Hepatic malignancy</keyword>
  <keyword>GGT</keyword>
  <keyword>living donor</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>Undecided</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/NCT04412161
org study id: GGT-HCC-6CM
nct id: NCT04412161
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with
      >6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP <200 ng/ml
      and GGT <104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in
      patient prognosis.
Background:A retrospective analysis was performed of prospectively-collected transplant data
      on outcomes of patients with large size HCCs,to examine possible prognostically-useful
      factors.Methods:A total of 50 patients having tumors greater than 6cm maximum diameter were
      identified. Their survival and full clinical characteristics were examined, with respect to
      serum AFP and GGT levels.Results:Using ROC analysis, cutoff values of AFP 200 ng/ml and GGT
      104 IU/ml were identified and used in this study. Significantly longer overall-survival and
      disease-free-survival were found for patients who had lower values of either parameter,
      compared with higher values.Even greater differences in survival were found when the 2
      parameters were combined, with best survival (5-year OS of 76,2% versus 0%, p=0.002).The most
      consistent clinical correlates for these longer survivals were degree of tumor
      differentiation and absence of microscopic portal venous invasion.Two tumor size bands were
      identified,to search for the limits of this approach with larger tumors, namely 6-10 and
      >10cm.Combination parameters in 6-10cm band reflected 5-year OS of 76,2% vs. 0%,in patients
      with low AFP plus low GGT vs. other groups.Beyond 10cm,no patients had low AFP plus low
      GGT.Conclusions:AFP and GGT,both singly and together, represent a simple prognostic
      identifier for patients with large size HCCs being treated by liver transplantation.
observational model: Cohort
time perspective: Retrospective
measure: overall and disease free survivals
time frame: five years follow up
description: to analyse the factors that effect the survivals
arm group label: Extra-Malatya
description: Liver transplant patients with MTD>6 cm of HCC
intervention type: Procedure
intervention name: Liver transplantation
description: Living donor liver transplantation
arm group label: Extra-Malatya
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Volkan Ince
investigator title: MD, FEBS, Assoc.Prof
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided