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

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ClinicalTrials.gov Identifier: NCT01316679
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

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
Hepatocellular Carcinoma Liver Disease

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 : March 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Groups and Cohorts

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from Vanderbilt internal medicine, hepatology, hepatobiliary surgery, and general surgery clinics.

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
More Information

Responsible Party: David L Gorden, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01316679     History of Changes
Other Study ID Numbers: Urinary Biomarkers 101423
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by David L Gorden, Vanderbilt University Medical Center:
Liver Disease without HCC

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases