Breast CancerNCT03681418
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
A study testing Ultrasound-guided axillary lymph nodes FNAC and\or CNB. in people with Breast Cancer, run by Assiut University.
Trial summary
The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 2021
- 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
- Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.
Who cannot join
- Patients who had previously undergone axillary surgery.
- Patients with metastatic disease and not planned for axillary surgery.
- Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
- Patients with severe uncorrectable bleeding diathesis.
- Patients refused to sign consent.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.
Read the detailed description
Axillary lymph node status is an extremely important prognostic factor in the assessment and treatment evaluation of patients with newly diagnosed breast cancer. Historically, axillary lymph node dissection (ALND) has been the reference standard for diagnosis and staging. However, this procedure can cause numerous postoperative problems, such as lymphedema , pain, impaired shoulder mobility and arm weakness. Furthermore, in this era of mammographic screening, axillary lymph node dissection yields negative results in 80%-85% of patients with T1 cancer.
Therefore, in recent years, sentinel lymph node biopsy (SNB) has replaced axillary dissection for lymph node staging at major medical centers. However, there are some practical issues to be resolved. For example, radiotracer distribution can be slow or faulty, valuable operating room time is expended, and pathologists must make quick decisions based on the analysis of frozen sections or there is the need to undergo two surgical interventions (i.e., removal of primary tumor and SNB, and in a next step completion ALND). If nodal positivity could be proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a decision will be made to perform axillary dissection, which is the standard of care in most node-positive patients.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
- Keywords
- Axillary Lymph Node Biopsy in Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.Procedure or surgery
Ultrasound-guided axillary lymph node fine needle aspiration and\or core needle biopsy of the most suspicious lymph node. If all the lymph nodes appeared similar or normal, the lymph node that is lowest in the axilla will be selected because it is considered to most likely be the sentinel node.
| Study group | Role | What they receive |
|---|---|---|
| Patients with operable breast cancer | Other | Ultrasound-guided axillary lymph nodes FNAC and\or CNB. Receives: Procedure: Ultrasound-guided axillary lymph nodes FNAC and\or CNB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
Accuracy will be determined by comparing the results of ultrasound-guided axillary lymph node biopsy to the gold standard which is the final pathological results from sentinel lymphadenectomy or axillary lymph node dissection.
Measured: Baseline.
Secondary outcomes (1)
Accuracy of ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with a recent diagnosis of ipsilateral breast cancer.
Ultrasound-guided fine needle aspiration and\or core needle biopsy of axillary lymph node of the patient.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai El-Moataz Bellah Mohamed El-Sadek Khedrawy, Assiut University
- Investigators
- Mai M. Khedrawy, M.B.B.CH, Principal investigator, Assiut UniversityHassan I. Metgally, professor, Study director, Assiut UniversityMomtaz T. Allam, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681418
- Sponsor's protocol ID
- LNs Staging of Breast cancer
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.
PubMed 12374657Kumar R, Jana S, Heiba SI, Dakhel M, Axelrod D, Siegel B, Bernik S, Mills C, Wallack M, Abdel-Dayem HM. Retrospective analysis of sentinel node localization in multifocal, multicentric, palpable, or nonpalpable breast cancer. J Nucl Med. 2003 Jan;44(1):7-10.
PubMed 12515869Mainiero MB, Cinelli CM, Koelliker SL, Graves TA, Chung MA. Axillary ultrasound and fine-needle aspiration in the preoperative evaluation of the breast cancer patient: an algorithm based on tumor size and lymph node appearance. AJR Am J Roentgenol. 2010 Nov;195(5):1261-7. doi: 10.2214/AJR.10.4414.
PubMed 20966338
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
- ClinicalTrials.gov ID
- NCT03681418
- Acronym / sponsor ID
- LNs Staging of Breast cancer
- Conditions
- Breast Cancer
- Keywords
- Axillary Lymph Node Biopsy in Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Sep 2018 (actual)
- 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.
The purpose of the study is to estimate the diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer, and also to compare between ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with breast cancer.
Detailed description
Axillary lymph node status is an extremely important prognostic factor in the assessment and treatment evaluation of patients with newly diagnosed breast cancer. Historically, axillary lymph node dissection (ALND) has been the reference standard for diagnosis and staging. However, this procedure can cause numerous postoperative problems, such as lymphedema , pain, impaired shoulder mobility and arm weakness. Furthermore, in this era of mammographic screening, axillary lymph node dissection yields negative results in 80%-85% of patients with T1 cancer.
Therefore, in recent years, sentinel lymph node biopsy (SNB) has replaced axillary dissection for lymph node staging at major medical centers. However, there are some practical issues to be resolved. For example, radiotracer distribution can be slow or faulty, valuable operating room time is expended, and pathologists must make quick decisions based on the analysis of frozen sections or there is the need to undergo two surgical interventions (i.e., removal of primary tumor and SNB, and in a next step completion ALND). If nodal positivity could be proven and documented preoperatively, sentinel lymph node biopsy could be bypassed and a decision will be made to perform axillary dissection, which is the standard of care in most node-positive patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with operable breast cancer | Other | Procedure: Ultrasound-guided axillary lymph nodes FNAC and\or CNB.Ultrasound-guided axillary lymph nodes FNAC and\or CNB. |
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)
- Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.
Key exclusion criteria (5 listed)
- Patients who had previously undergone axillary surgery.
- Patients with metastatic disease and not planned for axillary surgery.
- Patients with a preoperative diagnosis of a benign lesion or ductal carcinoma in situ.
- Patients with severe uncorrectable bleeding diathesis.
- Patients refused to sign consent.
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 |
|---|---|---|
| Ultrasound-guided axillary lymph nodes FNAC and\or CNB.Ultrasound-guided axillary lymph node fine needle aspiration and\or core needle biopsy of the most suspicious lymph node. If all the lymph nodes appeared similar or normal, the lymph node that is lowest in the axilla will be selected because it is considered to most likely be the sentinel node. | Procedure or surgery | Patients with operable breast cancer |
Primary outcome
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
Time frame: Baseline.
Accuracy will be determined by comparing the results of ultrasound-guided axillary lymph node biopsy to the gold standard which is the final pathological results from sentinel lymphadenectomy or axillary lymph node dissection.
1 secondary outcome
Accuracy of ultrasound-guided fine needle aspiration cytology and core needle biopsy in their ability to detect metastatic disease in the axillary lymph nodes of patients with a recent diagnosis of ipsilateral breast cancer.
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Background: PubMed 12374657Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.
- Background: PubMed 12515869Kumar R, Jana S, Heiba SI, Dakhel M, Axelrod D, Siegel B, Bernik S, Mills C, Wallack M, Abdel-Dayem HM. Retrospective analysis of sentinel node localization in multifocal, multicentric, palpable, or nonpalpable breast cancer. J Nucl Med. 2003 Jan;44(1):7-10.
- Background: PubMed 20966338Mainiero MB, Cinelli CM, Koelliker SL, Graves TA, Chung MA. Axillary ultrasound and fine-needle aspiration in the preoperative evaluation of the breast cancer patient: an algorithm based on tumor size and lymph node appearance. AJR Am J Roentgenol. 2010 Nov;195(5):1261-7. doi: 10.2214/AJR.10.4414.
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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.
Mai M. Khedrawy, M.B.B.CH principal investigator
Assiut University
Hassan I. Metgally, professor study director
Assiut University
Momtaz T. Allam, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided axillary lymph nodes FNAC and\or CNB. in people with Breast Cancer, run by Assiut University.
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 5 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mai M. Khedrawy, M.B.B.CH (00201028655822, mai.4cj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer. (time frame: Baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681418, which also lists 3 linked publications.
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 24 Sep 2018.