An Analysis of Urinary Proteases as Biomarkers for Hepato... | NCT01316679

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

NCT01316679

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 12, 2017Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma
Liver Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Mar 15, 2011

First Submission Date that Met QC Criteria

Mar 15, 2011

First Posted Date

Mar 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2017

Last Update Posted Date

Apr 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David L Gorden, Professor, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008107	Liver Diseases

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided