Palpable Breast MassNCT00595660
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
A study testing FNA - fine needle aspiration in people with Palpable Breast Mass, run by Kashani Social Security Hospital at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Palpable Breast Mass
- What is being tested?
- FNA - fine needle aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any Woman with palpable Breast Mass
Who cannot join
- Previous open Biopsy or Surgery
- Active infection
- Breast cysts
- Patient refusal to do FNA
Trial locations and contacts
1 site in 1 country.
Iran1 site
Kashani Social Security Hospital
Tehran, Tehran Province
Bijan Mohammadhosseini, General Surgeon,MD, +989121009677, bijanmh@Gmail.com
About this study
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.
Read the detailed description
Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24
- Conditions
- Palpable Breast Mass
- Being tested
- FNA - fine needle aspiration
- Keywords
- Palpable Breast Mass, FNA, Cytology, Fine needle aspiration, Specimen Adequacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA - fine needle aspirationProcedure or surgery
Fine Needle aspiration
FNA - fine needle aspirationProcedure or surgery
Fine needle aspiration
FNA - fine needle aspirationProcedure or surgery
Fine needle aspiration
FNA - fine needle aspirationProcedure or surgery
Fine needle aspiration
FNA - fine needle aspirationProcedure or surgery
Fine needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Needle 21 for FNA Receives: Procedure: FNA - fine needle aspiration |
| 2 | Active comparator | 22 needle for FNA Receives: Procedure: FNA - fine needle aspiration |
| 3 | Active comparator | 23 needle for FNA Receives: Procedure: FNA - fine needle aspiration |
| 4 | Active comparator | 24 needle for FNA Receives: Procedure: FNA - fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
specimen adequacy
Measured: 2 years
Secondary outcomes (1)
complication
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palpable Breast MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kashani Social Security Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bijan Mohammadhosseini, General Surgeon,MD, Principal investigator, Kashani Social Security Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595660
- Sponsor's protocol ID
- 17251-10/10/1386
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00595660
- Acronym / sponsor ID
- 17251-10/10/1386
- Conditions
- Palpable Breast Mass
- Keywords
- Palpable Breast Mass, FNA, Cytology, Fine needle aspiration, Specimen Adequacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kashani Social Security HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (estimated)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: FNA - fine needle aspirationNeedle 21 for FNA |
| 2 | Active comparator | Procedure: FNA - fine needle aspiration22 needle for FNA |
| 3 | Active comparator | Procedure: FNA - fine needle aspiration23 needle for FNA |
| 4 | Active comparator | Procedure: FNA - fine needle aspiration24 needle for FNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any Woman with palpable Breast Mass
Key exclusion criteria (4 listed)
- Previous open Biopsy or Surgery
- Active infection
- Breast cysts
- Patient refusal to do FNA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNA - fine needle aspirationFine Needle aspiration | Procedure or surgery | 1, 2, 3, 4 |
| FNA - fine needle aspirationFine needle aspiration | Procedure or surgery | 1 |
| FNA - fine needle aspirationFine needle aspiration | Procedure or surgery | 2 |
| FNA - fine needle aspirationFine needle aspiration | Procedure or surgery | 3 |
| FNA - fine needle aspirationFine needle aspiration | Procedure or surgery | 4 |
Primary outcome
specimen adequacy
Time frame: 2 years
1 secondary outcome
complication
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bijan Mohammadhosseini, General Surgeon,MD principal investigator
Kashani Social Security Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FNA - fine needle aspiration in people with Palpable Breast Mass, run by Kashani Social Security Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bijan -- Mohammadhosseini, General Surgeon,MD (+989121009677, bijanmh@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specimen adequacy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008.