NOTEGS
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.
Sponsor study identifier
Secondary identifiers
OTHER · Assistance Publique - Hôpitaux de Paris
observational
3,194
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 6, 2011
Actual (reported)January 13, 2012
Actual (reported)July 2013
Actual (reported)July 2013
Actual (reported)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.
after the surgery
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
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.
To provide probability of non sentinel lymph node metastasis in case of metastatic lymph node according to MSKCC nomogram and Tenon score.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital Tenon, 4 rue de la Chine
Paris, 75020, France
Roman Rouzier, MD, PhD
Assistance Publique - Hôpitaux de Paris
3,194 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2011
First Posted
January 13, 2012
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not
Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
August 5, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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