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

April 10, 2017 updated by: David L Gorden, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

87

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from Vanderbilt internal medicine, hepatology, hepatobiliary surgery, and general surgery clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urinary Biomarkers 101423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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