Duke Urology Database and Specimen Bank | NCT00978991

Studies
Duke Urology Database and Specimen Bank

NCT00978991

Sponsor

Duke University

Status

Completed

Last Update Posted

Feb 8, 2013Estimated

Enrollment

87,820Actual

Phase

Not provided

Conditions

Prostate Cancer
Bladder Cancer
Erectile Dysfunction
Incontinence

Interventions

Not provided

Countries

United States

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

Feb 2013

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

Jan 1988

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Sep 15, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

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

Feb 6, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The proposed project is aimed to build a Duke University-specific longitudinal urologic surgery database. It will be used as the main resource to support future research within Urology and Duke University.

Detailed Description

Specifically, the database will be used for the following future studies. (i) To characterize the biomarkers/protein signature associated with urological diseases; (ii) To clarify the clinical role of the risk factors and their interactions for early detection and optimized treatment of urological diseases, and improvement of post-treatment quality of life; (iii) To develop algorithms and nomograms to accurately predict the outcome of urological diseases.

Retrospective review of subjects data prior to Institutional Review Board approval and prospective review of data on those consented after Institutional Review Board approval.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

87,820Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Duke Urology patients

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Urology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judd W Moul, MD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D001749	Urinary Bladder Neoplasms
D007172	Erectile Dysfunction
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided