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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014