Breast CancerNCT02019303
Accuracy of FNA Versus CNB of Abnormal Axillary Lymph Nodes in Setting of Invasive Breast Cancer
A study testing FNA and Core biopsy in people with Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FNA and Core biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 30 Apr 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
- Able to provide informed consent
Who cannot join
- Lymph node not amenable to core biopsy
- Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Ultrasound Guided Core Needle Biopsy Versus Fine Needle Aspiration of Morphologically Abnormal Axillary Lymph Node in Patients With New Diagnosis or Suspected Diagnosis of Invasive Breast Carcinoma
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer.
Hypothesis: FNA and CNB have equivalent diagnostic accuracies
In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample.
The results of the biopsies will be compared to the gold standard (lymph node excision).
- Conditions
- Breast Cancer
- Being tested
- FNA and Core biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA and Core biopsyProcedure or surgery
Both procedures will be performed on the same lymph node
| Study group | Role | What they receive |
|---|---|---|
| Abnormal lymph nodes | Other | There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound. Receives: Procedure: FNA and Core biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of FNA and CNB
Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.
Measured: 2 years
Secondary outcomes (1)
Pain associated with FNA and CNB
Pain associated with each biopsy method will be assessed with a visual analog scale (0- 10) after a baseline pain measurement. The results will be compared to baseline pain level and analyzed using a paired t test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Responsible party
- Principal investigator, Nicole Winkler, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019303
- Sponsor's protocol ID
- 00068472
- Status last verified
- Oct 2022
- First submitted
- 3 Dec 2013
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Core Needle Biopsy Versus Fine Needle Aspiration of Morphologically Abnormal Axillary Lymph Node in Patients With New Diagnosis or Suspected Diagnosis of Invasive Breast Carcinoma
- ClinicalTrials.gov ID
- NCT02019303
- Acronym / sponsor ID
- 00068472
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Study start
- Feb 2014 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 24 Dec 2013 (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.
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer.
Hypothesis: FNA and CNB have equivalent diagnostic accuracies
In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample.
The results of the biopsies will be compared to the gold standard (lymph node excision).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abnormal lymph nodes | Other | Procedure: FNA and Core biopsyThere is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Lymph node not amenable to core biopsy
- Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
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 and Core biopsyBoth procedures will be performed on the same lymph node | Procedure or surgery | Abnormal lymph nodes |
Primary outcome
Accuracy of FNA and CNB
Time frame: 2 years
Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.
1 secondary outcome
Pain associated with FNA and CNB
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Core biopsy in people with Breast Cancer, run by University of Utah at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Nov 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of FNA and CNB (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 1 Nov 2022.