NCT00293865已完成不适用
Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Institut Cancerologie de l'Ouest32 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 32
- 主要终点
- false negatives
研究概览
简要总结
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Previous conservative surgical biopsy
- •Secondary pathological diagnosis of infiltrative cancer
- •No clinically involved axillary node (N0)
- •No previous neoadjuvant treatment
- •Performance status European Cancer Conference (ECCO) Grade ≤ 1
- •Patient's written informed consent to participate in the study according to French law
- •Surgeon must have performed its learning curve
排除标准
- •Lack of infiltrative breast carcinoma (in situ) pT4d > N0
- •Breast cancer relapse
- •Pregnancy
- •Known patent blue allergy
- •Indication for radical or partial mastectomy
- •Patient unable to understand the trial
结局指标
主要结局
false negatives
次要结局
未报告次要终点
研究者
研究点 (32)
Loading locations...
相似试验
已完成
不适用
Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence ImagingEndometrial CancerCervical CancerNCT01673022Indiana University430
招募中
不适用
Sentinel Lymph Node in Early-Stage Endometrium CancerSentinel Lymph NodeEndometrial CancerNCT06163963Istanbul University100
已完成
不适用
Sentinel Lymph Node Detection in Prostate Surgery by LaparoscopyProstatic NeoplasmsNCT01296217Centre René Gauducheau24
Unknown
3 期
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.Breast CancerNCT02249208Hospital Universitari Vall d'Hebron Research Institute150
已完成
不适用
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section HistopathologyBreast NeoplasmsBreast DiseasesNCT01368744Sysmex America, Inc.150