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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was  Not yet recruiting
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:


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
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

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
Carcinoma, Hepatocellular
Liver Diseases
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2014