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

This study is not yet open for participant recruitment.
Verified March 2011 by Vanderbilt University
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01316679
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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
Hepatocellular Carcinoma
Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:

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

Further study details as provided by Vanderbilt University:

Estimated Enrollment: 75
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vanderbilt University / David Lee Gorden, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01316679     History of Changes
Other Study ID Numbers: Urinary Biomarkers 101423
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
HCC
Liver Disease without HCC

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

ClinicalTrials.gov processed this record on May 23, 2013