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

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ClinicalTrials.gov Identifier: NCT00595660
Recruitment Status : Unknown
Verified January 2008 by Kashani Social Security Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:
Kashani Social Security Hospital

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.

Condition or disease Intervention/treatment Phase
Palpable Breast Mass Procedure: FNA - fine needle aspiration Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
Study Start Date : February 2008
Estimated Primary Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: 1
Needle 21 for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 2
22 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 3
23 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration
Active Comparator: 4
24 needle for FNA
Procedure: FNA - fine needle aspiration
Fine Needle aspiration
Procedure: FNA - fine needle aspiration
Fine needle aspiration



Primary Outcome Measures :
  1. specimen adequacy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. complication [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595660


Contacts
Contact: Bijan -- Mohammadhosseini, General Surgeon,MD +989121009677 bijanmh@Gmail.com

Locations
Iran, Islamic Republic of
Kashani Social Security Hospital Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Bijan Mohammadhosseini, General Surgeon,MD    +989121009677    bijanmh@Gmail.com   
Sponsors and Collaborators
Kashani Social Security Hospital
Investigators
Principal Investigator: Bijan Mohammadhosseini, General Surgeon,MD Kashani Social Security Hospital

Responsible Party: Dr.Hamidzadeh, Kashani Social Security Hospital
ClinicalTrials.gov Identifier: NCT00595660     History of Changes
Other Study ID Numbers: 17251-10/10/1386
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by Kashani Social Security Hospital:
Palpable Breast Mass
FNA
Cytology
Fine needle aspiration
Specimen Adequacy