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Sentinel Node and Endometrial Cancer (Senti-Endo)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00987051
First received: July 30, 2009
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.


Condition Intervention
Endometrial Neoplasms
 Procedure: Detection of sentinel node

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of the Sentinel Node in Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Detection and false negative rates of sentinel node [ Time Frame: During the surgery (hysterectomy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity and recurrence rates [ Time Frame: During 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: April 2007
Study Completion Date: October 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with endometrial cancer
 Procedure: Detection of sentinel node
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection
Other Name: Detection of sentinel node

Detailed Description:

To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient over 18 years old with a surgery planned for endometrial cancer
  • endometrial cancer proved by biopsy
  • early stage of endometrial cancer (FIGO stage 1-2)
  • without contraindication to surgery
  • inform consent signed
  • affiliated to general health system

Exclusion Criteria:

  • endometrial cancer FIGO stages 3-4
  • previous history of surgery modifying lymphatic drainage (conization myomectomy)
  • pregnant women or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987051

Locations
France
Tenon Hospital
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Emile DARAÏ, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00987051     History of Changes
Other Study ID Numbers: P060229
Study First Received: July 30, 2009
Last Updated: December 10, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
sentinel node procedure
radiocolloid
patent blue

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2013