The Memorial Sloan-Kettering Cancer Center (MSKCC (NOTEGS)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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.|
- 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. [ Time Frame: after the surgery ] [ Designated as safety issue: No ]
- 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. [ Time Frame: after the surgery ] [ Designated as safety issue: No ]
- 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. [ Time Frame: after the surgery ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
patients candidates for the SN procedure
The study will focus on patients candidates for the SN procedure as recommended by Saint-Paul de VENCE initially in 2005 but modified in 2009.
Other: no intervention : measure of score
To provide probability of non sentinel lymph node metastasis in case of metastatic lymph node according to MSKCC nomogram and Tenon score.
Other Name: no intervention : measure of score
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|Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital Tenon, 4 rue de la Chine|
|Paris, France, 75020|
|Principal Investigator:||Roman Rouzier, MD, PhD||Assistance Publique - Hôpitaux de Paris|