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

NCT ID: NCT00595660

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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

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

Conditions

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Palpable Breast Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Needle 21 for FNA

Group Type ACTIVE_COMPARATOR

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine Needle aspiration

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration

2

22 needle for FNA

Group Type ACTIVE_COMPARATOR

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine Needle aspiration

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration

3

23 needle for FNA

Group Type ACTIVE_COMPARATOR

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine Needle aspiration

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration

4

24 needle for FNA

Group Type ACTIVE_COMPARATOR

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine Needle aspiration

FNA - fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration

Interventions

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FNA - fine needle aspiration

Fine Needle aspiration

Intervention Type PROCEDURE

FNA - fine needle aspiration

Fine needle aspiration

Intervention Type PROCEDURE

FNA - fine needle aspiration

Fine needle aspiration

Intervention Type PROCEDURE

FNA - fine needle aspiration

Fine needle aspiration

Intervention Type PROCEDURE

FNA - fine needle aspiration

Fine needle aspiration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any Woman with palpable Breast Mass

Exclusion Criteria

* Previous open Biopsy or Surgery
* Active infection
* Breast cysts
* Patient refusal to do FNA
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kashani Social Security Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kashani Social Security Hospital

Principal Investigators

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Bijan Mohammadhosseini, General Surgeon,MD

Role: PRINCIPAL_INVESTIGATOR

Kashani Social Security Hospital

Locations

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Kashani Social Security Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Central Contacts

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Bijan -- Mohammadhosseini, General Surgeon,MD

Role: CONTACT

+989121009677

Facility Contacts

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Bijan Mohammadhosseini, General Surgeon,MD

Role: primary

+989121009677

Other Identifiers

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17251-10/10/1386

Identifier Type: -

Identifier Source: org_study_id

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