NCT01316679

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

March 15, 2011

Last Update Submit

April 10, 2017

Conditions

Hepatocellular CarcinomaLiver Disease

Keywords

HCCLiver Disease without HCC

Study Arms (3)

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 Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Suspected inability, e.g. unwillingness to comply with study procedures or unwillingness to provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Diseases

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 12, 2017

Record last verified: 2017-04