Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
January 15, 2008 updated by: Kashani Social Security Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Kashani Social Security Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Any Woman with palpable Breast Mass
Exclusion Criteria:
- Previous open Biopsy or Surgery
- Active infection
- Breast cysts
- Patient refusal to do FNA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Needle 21 for FNA
|
Fine Needle aspiration
Fine needle aspiration
|
|
Active Comparator: 2
22 needle for FNA
|
Fine Needle aspiration
Fine needle aspiration
|
|
Active Comparator: 3
23 needle for FNA
|
Fine Needle aspiration
Fine needle aspiration
|
|
Active Comparator: 4
24 needle for FNA
|
Fine Needle aspiration
Fine needle aspiration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
specimen adequacy
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
complication
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bijan Mohammadhosseini, General Surgeon,MD, Kashani Social Security Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Anticipated)
February 1, 2010
Study Registration Dates
First Submitted
January 7, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
January 16, 2008
Last Update Submitted That Met QC Criteria
January 15, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 17251-10/10/1386
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.