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

NCT03681418 | Unknown

• 1 other identifier: LNs Staging of Breast cancer
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Axillary Lymph Node Biopsy in Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline.

Study Arms (1)

Patients with operable breast cancer

OTHER

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

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

Interventions

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

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.

Patients with operable breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 12374657 BACKGROUND

• 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.

  PMID: 12515869 BACKGROUND

• 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.

  PMID: 20966338 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mai M. Khedrawy, M.B.B.CH

  Assiut University

  PRINCIPAL INVESTIGATOR

• Hassan I. Metgally, professor

  Assiut University

  STUDY DIRECTOR

• Momtaz T. Allam, Lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mai M. Khedrawy, M.B.B.CH

CONTACT

00201028655822; mai.4cj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 24, 2018

Record last verified: 2018-09