Sentinel Node and Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Neoplasms
• Interventions: Procedure: Detection of sentinel node

• Registration Number: NCT00987051
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2009-12
• Study Completion: 2011-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 133

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

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Exclusion Criteria

• endometrial cancer FIGO stages 3-4
• previous history of surgery modifying lymphatic drainage (conization myomectomy)
• pregnant women or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Detection of sentinel node	Patients with endometrial cancer

Primary Outcome Measures

Name	Time	Method
Detection and false negative rates of sentinel node	During the surgery (hysterectomy)

Secondary Outcome Measures

Name	Time	Method
Morbidity and recurrence rates	During 24 months

Trial Locations

Locations (1)

Tenon Hospital; 🇫🇷 Paris, France