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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David L Gorden, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01316679
First received: March 15, 2011
Last updated: April 10, 2017
Last verified: April 2017
  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
Official Title: An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Enrollment: 87
Actual Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: January 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   (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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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
Study First Received: March 15, 2011
Last Updated: April 10, 2017

Keywords provided by Vanderbilt University Medical Center:
HCC
Liver Disease without HCC

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

ClinicalTrials.gov processed this record on April 26, 2017