Best Needle Size for FNA of Palpable Breast Mass:Randomis... | NCT00595660

Studies
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study

NCT00595660

Sponsor

Kashani Social Security Hospital

Status

Unknown status

Last Update Posted

Jan 16, 2008Estimated

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Palpable Breast Mass

Interventions

FNA - fine needle aspiration
FNA - fine needle aspiration
FNA - fine needle aspiration
FNA - fine needle aspiration
FNA - fine needle aspiration

Countries

Iran

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

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2010Estimated

Completion Date

Not provided

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 16, 2008Estimated

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

Jan 15, 2008

Last Update Posted Date

Jan 16, 2008Estimated

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

Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.

Detailed Description

Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24

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

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Needle 21 for FNA	Procedure: FNA - fine needle aspiration
2	Active Comparator	22 needle for FNA	Procedure: FNA - fine needle aspiration
3	Active Comparator	23 needle for FNA	Procedure: FNA - fine needle aspiration
4	Active Comparator	24 needle for FNA	Procedure: FNA - fine needle aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FNA - fine needle aspiration	Procedure	Fine Needle aspiration	1 2 3 4

Measure	Description	Time Frame
specimen adequacy		2 years

Measure	Description	Time Frame
complication		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any Woman with palpable Breast Mass

Exclusion Criteria:

Previous open Biopsy or Surgery
Active infection
Breast cysts
Patient refusal to do FNA

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bijan -- Mohammadhosseini, General Surgeon,MD	Contact	+989121009677		bijanmh@Gmail.com

Overall Officials

Name	Affiliation	Role
Bijan Mohammadhosseini, General Surgeon,MD	Kashani Social Security Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kashani Social Security Hospital		Tehran	Tehran Province		Iran

Intervention Browse Module

MeSH Terms

ID	Term
D044963	Biopsy, Fine-Needle

Ancestor Terms

ID	Term
D001707	Biopsy, Needle
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided