<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/NCT04477720</url>
  </required_header>
  <id_info>
    <org_study_id>BCarr</org_study_id>
    <nct_id>NCT04477720</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of De-identified Deceased HCC Patients</brief_title>
  <official_title>HCC Observation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carr, Brian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carr, Brian</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>
      De-identified deceased HCC patients who were not surgical candidates were evaluated for their&#xD;
      clinical baseline characteristics associated with their survival. Baselines included tumor&#xD;
      markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and&#xD;
      presence of portal vein thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1995</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <primary_completion_date type="Actual">May 2009</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>Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival</description>
  </primary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Survival</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting for HCC management&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biopsy-proven HCC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Yes</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCC, AFP, MTD, survival, NLR, PLR, Tumor Aggressiveness</keyword>
  <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/NCT04477720
org study id: BCarr
nct id: NCT04477720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
De-identified deceased HCC patients who were not surgical candidates were evaluated for their
      clinical baseline characteristics associated with their survival. Baselines included tumor
      markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and
      presence of portal vein thrombosis.
observational model: Cohort
time perspective: Retrospective
measure: Survival
time frame: 10 years
description: Overall survival
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: Undecided