Korean Practice Patterns for Screening PCA(Prostate Cancer) | NCT01371513

Studies
Korean Practice Patterns for Screening PCA(Prostate Cancer)

NCT01371513

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 22, 2017Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Neoplasms, Prostate
Prostate Cancer
Benign Prostatic Hyperplasia

Interventions

continuous screening

Countries

South Korea

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

May 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

May 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 12, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 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

May 19, 2017

Last Update Posted Date

May 22, 2017Actual

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

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Detailed Description

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSA level		more than 2.5ng/ml	Other: continuous screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous screening	Other	practice patterns for screening prostate cancer	PSA level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with prostate biopsy		1year

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects with prostate cancer		1year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008

Exclusion Criteria:

Age less than 40 at PSA screening
History of drug use which can affect level of PSA within 6months before PSA screening
Subject who participate any other clinical trial

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with PSA more than 2.5ng/ml in 2008 from urology department of clinic and general hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Seoul		135-720	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
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