A Test of the Comparison Between Trans-rectal and Trans-p... | NCT01849835

Studies
A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate

NCT01849835

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

May 6, 2014Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Complication

Interventions

trans-rectal to perform the prostate biopsy
trans-perineal to perform the prostate biopsy

Countries

China

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

ID	Type	Description	Link
tongji10-us1

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Apr 29, 2013

First Submission Date that Met QC Criteria

May 8, 2013

First Posted Date

May 9, 2013Estimated

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 4, 2014

Last Update Posted Date

May 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Le-hang Guo, Principal Investigator, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Not provided

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 purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
trans-rectal	Experimental	trans-rectal to perform the prostate biopsy	Procedure: trans-rectal to perform the prostate biopsy
trans-perineal	Experimental	trans-perineal to perform the prostate biopsy	Procedure: trans-perineal to perform the prostate biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trans-rectal to perform the prostate biopsy	Procedure	the puncture points are at the rectal	trans-rectal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the rate of positive detections		1year

Secondary Outcomes

Measure	Description	Time Frame
the incidence rate of each complication		1 year

Other Outcomes

Measure	Description	Time Frame
pain level assessed by visual analogue scale		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

prostate-specific antigen > 4ng/ml
Palpation is positive

Exclusion Criteria:

older than 80y
prostate-specific antigen > 100 ng/ml

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
guo lehang, phd	Contact	+8613764538305		gopp1314@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
10Th Hospital of Tongji University	Recruiting	Shanghai	Shanghai Municipality	200072	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate