Sentinel Node and Endometrial Cancer

Validation of the Sentinel Node in Endometrial Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987051

Acronym

Senti-Endo

Enrollment

133

Registered

2009-09-30

Start date

2007-04-30

Completion date

2011-10-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms

Keywords

sentinel node procedure, radiocolloid, patent blue

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.

Interventions

PROCEDUREDetection of sentinel node

Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Detection and false negative rates of sentinel node	During the surgery (hysterectomy)

Secondary

Measure	Time frame
Morbidity and recurrence rates	During 24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026