跳至主要内容
临床试验/NCT02455791
NCT02455791
进行中(未招募)
不适用

Pilot Study for Identification of Breast Cancer Patients for Potential Avoidance of Surgery: Accuracy of Image Guided Percutaneous Sampling Compared With Surgery to Evaluate Eradication of Breast Cancer After Preoperative Chemotherapy

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 43 人2015年6月24日

概览

阶段
不适用
干预措施
Ultrasound-Guided Biopsy
疾病 / 适应症
Breast Cancer
发起方
M.D. Anderson Cancer Center
入组人数
43
试验地点
1
主要终点
Diagnostic Accuracy of Ultrasound-Guided FNA and Core Biopsy of Initial Breast Cancer Region Compared to Standard Surgery with Pathologic Evaluation
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

The goal of this clinical research study is to compare the use of an ultrasound-guided biopsy with what is found during surgery in finding evidence of the disease.

详细描述

If you agree to take part in this study, you will have an ultrasound-guided biopsy of the tumor site. To perform this biopsy, a needle is inserted into the affected area using an ultrasound to collect cells or tissue from a tumor mass. The doctor will use the ultrasound to guide the needle into the area. Two (2) types of samples will be collected: a fine needle aspirate (FNA) that collects cells and a core biopsy that collects a small piece of tissue. If the tumor is not seen well by the ultrasound, the study doctor may use a mammogram to perform the biopsy. You will then have the same planned surgery and post-operative care that you would normally have. You will sign a separate consent for your surgery. Your medical records may be reviewed and information recorded from your routine follow-up visits in order to follow your general health and the outcome of your surgery. Length of Study Participation: Your active participation in this study will be finished when you have had your surgery and completed your post-operative care. This is an investigational study. It is investigational to compare the use of an ultrasound-guided biopsy with what is found during surgery in finding evidence of the disease. Up to 40 participants will take part on this study. All will be enrolled at MD Anderson.

注册库
clinicaltrials.gov
开始日期
2015年6月24日
结束日期
2026年12月31日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

  • \>/= 18 years old
  • Histologic diagnosis of triple negative or HER2 amplified breast cancer, clinical stage T1-4, N0-3, M0/1 receiving preoperative systemic therapy and planned surgery

排除标准

  • 未提供

研究组 & 干预措施

Ultrasound-Guided Biopsy of Tumor Site

Ultrasound-guided biopsy of the tumor site performed before scheduled surgery.

干预措施: Ultrasound-Guided Biopsy

结局指标

主要结局

Diagnostic Accuracy of Ultrasound-Guided FNA and Core Biopsy of Initial Breast Cancer Region Compared to Standard Surgery with Pathologic Evaluation

时间窗: 1 day

Accuracy of FNA and core biopsy determined by comparing these biopsy results to the pathologic evaluation removed during standard surgery. Estimates and 95% confidence intervals for accuracy, sensitivity, false negative rate (FNR), specificity as well as the negative predictive value (NPV) reported for FNA and core biopsy based on the exact Clopper-Pearson method.

研究点 (1)

Loading locations...

相似试验