Prospective Evaluation of the Reliability of the Combined Use of Two Models to Predict Non-sentinel Lymph Node Status in Breast Cancer Patients With Metastatic Sentinel Lymph Nodes: the MSKCC Nomogram and the Tenon Score.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,194
- 试验地点
- 1
- 主要终点
- False negative rate in patients with both a ≤ 10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ≤ 3.5 (i.e. low risk): proportion of patients with metastatic non-SN at additional ALND.
研究概览
简要总结
The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom additional axillary lymph node dissection (ALND) could be avoided.
详细描述
EXPERIMENTAL PLAN AND COURSE OF STUDY This is a prospective non-randomized non-interventional multicenter study including the respect of a quality charter and involving a prospective registration of clinical and histological data to test the hypothesis of a proportion of false negative rate (=rate of metastatic SN) of 5% +/- 5% within the population at low risk by the combined use of the MSKCC nomogram and Tenon score. No modification therapy will be conducted because the scores will not be provided to operators.
6.1 Conduct of the study 6.1.1 Before and during surgery Every surgeon agreeing to participate in the study - and thus to respect the quality charter - will make the inclusion of his eligible patients with an e-CRF which will generate automatically a number of anonymity. A form of inclusion specifying the number of anonymity of the patient, the initials of the name and the first name as well as the date of birth of the patient will be send back by e-mail by the study coordinator and clinical study technician (CST) of the URC-Est. The surgeon will have at his disposal 60 boards of labels of anonymity elaborated by the CST of the URC-Est corresponding to 30 patients (2 boards of labels by patient). The resupplying of labels will be managed by the CST.
A label will contain i) the number of anonymity, ii) the address and phone number of the surgeon, iii) the address and phone number of the pathology laboratory, iv) the address and phone number of the study coordinator including fax number where pathological results should be send.
During the first intervention, the surgeon will send the histological specimen (i.e. lumpectomy or mastectomy, SN, and possibly non-SN in case the ALND is completed during the first surgical procedure with a board of labels of anonymity.
In case of additional surgical procedure to complete ALND, the histological specimen (i.e. non-SN) will be sent to the pathology laboratory with the second board of label of anonymity corresponding to this patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged over 18 years old with invasive breast cancer with an indication of SN procedure as recommended by Saint-Paul de VENCE in 2005 amended in 2009
- •T1-2 breast cancer
- •Patients having social security coverage.
排除标准
- •Patient under the age of
- •Patient who had neoadjuvant chemotherapy.
- •Patient who had had radiotherapy to the ipsilateral axilla or breast.
- •Pregnant patient.
- •Patients who do not speak French.
- •Patients refusing to participate in the study.
- •Simultaneous participation in another research period of exclusion
结局指标
主要结局
False negative rate in patients with both a ≤ 10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ≤ 3.5 (i.e. low risk): proportion of patients with metastatic non-SN at additional ALND.
时间窗: after the surgery
次要结局
- To determine the impact on the reliability of the combined predictor of frozen section examination in light of his achievement or not, and its sensitivity.(after the surgery)
- To allow, because of the large number of patients to include in the study, the diffusion of a charter of quality for the SN procedure.(after the surgery)