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Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Axillary Lymph Node Biopsy in Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with operable breast cancer

    Arm Description

    Ultrasound-guided axillary lymph nodes FNAC and\or CNB.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 20, 2018
    Last Updated
    September 21, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03681418
    Brief Title
    Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
    Official Title
    Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Axillary Lymph Node Biopsy in Breast Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with operable breast cancer
    Arm Type
    Other
    Arm Description
    Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided axillary lymph nodes FNAC and\or CNB.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Diagnostic accuracy of preoperative ultrasound-guided axillary lymph node biopsy for staging in patients with newly diagnosed breast cancer.
    Description
    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.
    Time Frame
    Baseline.
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    Ultrasound-guided fine needle aspiration and\or core needle biopsy of axillary lymph node of the patient.
    Time Frame
    Baseline.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed patients with operable breast cancer regardless of whether lymph nodes are suspicious or not. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai M. Khedrawy, M.B.B.CH
    Phone
    00201028655822
    Email
    mai.4cj@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mai M. Khedrawy, M.B.B.CH
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hassan I. Metgally, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Momtaz T. Allam, Lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12374657
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12515869
    Citation
    Kumar 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.
    Results Reference
    background
    PubMed Identifier
    20966338
    Citation
    Mainiero 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.
    Results Reference
    background

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    Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.

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