The Memorial Sloan-Kettering Cancer Center (MSKCC (NOTEGS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01509963
First received: December 6, 2011
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Other: no intervention : measure of score

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3194
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient under the age of 18.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509963

Locations
France
Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital Tenon, 4 rue de la Chine
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Roman Rouzier, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01509963     History of Changes
Other Study ID Numbers: NI 10073, AOM 10220
Study First Received: December 6, 2011
Last Updated: August 2, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
MSKCC nomogram
Tenon score
metastatic SN
low risk of metastatic non-SN
additional ALND

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014