Sentinel Node and Endometrial Cancer (Senti-Endo)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Endometrial Neoplasms

Treatments: Procedure: Detection of sentinel node

Study type: Interventional

Funder types: Other

Identifiers

NCT00987051

P060229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

1

Experimental group

Description:

Patients with endometrial cancer

Treatment:

Procedure: Detection of sentinel node