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临床试验/CTRI/2025/08/092742
CTRI/2025/08/092742尚未招募不适用

Preoperative Sonographic Features of Axillary Lymphnodes as Predictors of Malignant Involvement in Biopsy - Proven Breast Cancer?

未提供1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Ultrasound features predicting malignancy with final histopathology as gold standard

研究概览

简要总结

Introduction

In our hospital’s surgical oncology department, the practice regarding addressing the axilla in breast cancer is to go through a tumour board. For patients planned for upfront surgery and not anterior chemotheapy by the tumour board, broadly clinicoradiologically axilla negative patients receive Sentinel node biopsy ( SLNB)and those who are clinically or radiologically axillary lymph node positive will receive an axillary dissection.

This research was thought of as to determine which imaging characteristics of axillary lymph nodes should be considered as high chance of being metastatic to decide on if SLNB or axillary dissection should be performed upfront.

Materials and Methods

All patients with biopsy-proven invasive breast cancer who are decided for upfront surgery in the tumour board are considered for the study.  Written informed consent in the regional language was obtained from each patient regarding enrollment in the study.  An axillary ultrasound is done a day prior to surgery for all consented patients. The ultrasound features are documented in profomas. Surgery is completed, and the axilla is addressed in the existing manner of the hospital.  A clinicoradiological negative axilla undergoes SLNB, and a positive one axillary dissection.

After the trial,  final histopathology is correlated with the ultrasound characteristics to see which are the best predictive USG characteristics in nodal involvement of breast cancer.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • invasive breast cancer diagnosed in pathology No chemotherapy received prior to axillary staging procedure.

排除标准

  • Phyllodes , sarcoma breast , insitu disease only , are excluded.

结局指标

主要结局

Ultrasound features predicting malignancy with final histopathology as gold standard

时间窗: Presurgery assessment | Post surgery pathology review at 4 weeks

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Amilu Elsa Varghese

Govt medical college hospital Kottayam

研究点 (1)

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