Breast Cancer Clinical Trial
Official title:
Role of Ultrasound-Guided Lymph Node Biopsy in Axillary Staging of Breast Cancer.
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline. |
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