Sentinel Node and Endometrial Cancer

Endometrial Neoplasms Clinical Trial

— Senti-Endo  

Official title:

Validation of the Sentinel Node in Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987051
• Other study ID #: P060229
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: December 10, 2012
• Start date: April 2007
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Procedure:
• Detection of sentinel node
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection

Locations

Country	Name	City	State
France	Tenon Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and false negative rates of sentinel node		During the surgery (hysterectomy)	No
Secondary	Morbidity and recurrence rates		During 24 months	Yes