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

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ClinicalTrials.gov Identifier: NCT01509963
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Other: no intervention : measure of score

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Study Design
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Study Type : Observational
Actual Enrollment : 3194 participants
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.
Study Start Date : December 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509963


Locations
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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
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Principal Investigator: Roman Rouzier, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01509963     History of Changes
Other Study ID Numbers: NI 10073
AOM 10220 ( Other Identifier: Assistance Publique - Hôpitaux de Paris )
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases