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An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01316679
Collaborator
(none)
87
Enrollment
22.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Specific urine proteases or groups of these enzymes can be reliable biomarkers and an effective gauge of response to therapy in patients with hepatocellular carcinoma.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    87 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423
    Actual Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    group A

    Patients with known HCC
    Group B

    Patients with liver disease but no HCC
    Group C

    Control; patients with no known liver disease or HCC

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Ability and willingness to provide written informed consent

      • Must be between 18-90 years of age at the time of consent

      • Ability to provide urine specimen at protocol-defined timepoints

      • Must have treatment interventions planned that are directly related to liver disease (excluding those assigned to group 3-Controls)

      Exclusion Criteria:
      • Suspected inability, e.g. unwillingness to comply with study procedures or unwillingness to provide written consent

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Vanderbilt University Medical Center

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      David L Gorden, Professor, Vanderbilt University Medical Center
      ClinicalTrials.gov Identifier:
      NCT01316679
      Other Study ID Numbers:
      • Urinary Biomarkers 101423
      First Posted:
      Mar 16, 2011
      Last Update Posted:
      Apr 12, 2017
      Last Verified:
      Apr 1, 2017
      Keywords provided by David L Gorden, Professor, Vanderbilt University Medical Center
      HCC
      Liver Disease without HCC
      Additional relevant MeSH terms:
      Carcinoma
      Carcinoma, Hepatocellular
      Liver Diseases

      Study Results

      No Results Posted as of Apr 12, 2017