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

NCT ID: NCT01316679

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group A

Patients with known HCC

No interventions assigned to this group

Group B

Patients with liver disease but no HCC

No interventions assigned to this group

Group C

Control; patients with no known liver disease or HCC

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David L Gorden

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Urinary Biomarkers 101423

Identifier Type: -

Identifier Source: org_study_id

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