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Sentinel Node and Endometrial Cancer (Senti-Endo)

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ClinicalTrials.gov Identifier: NCT00987051
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Endometrial Neoplasms Procedure: Detection of sentinel node Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of the Sentinel Node in Endometrial Cancer
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: 1
Patients with endometrial cancer
Procedure: Detection of sentinel node
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection



Primary Outcome Measures :
  1. Detection and false negative rates of sentinel node [ Time Frame: During the surgery (hysterectomy) ]

Secondary Outcome Measures :
  1. Morbidity and recurrence rates [ Time Frame: During 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

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): 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

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
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female