Sentinel Node and Endometrial Cancer
Senti-Endo
Validation of the Sentinel Node in Endometrial Cancer
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 11, 2012
December 1, 2012
2.7 years
July 30, 2009
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection and false negative rates of sentinel node
During the surgery (hysterectomy)
Secondary Outcomes (1)
Morbidity and recurrence rates
During 24 months
Study Arms (1)
1
EXPERIMENTALPatients with endometrial cancer
Interventions
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- endometrial cancer FIGO stages 3-4
- previous history of surgery modifying lymphatic drainage (conization myomectomy)
- pregnant women or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tenon Hospital
Paris, 75020, France
Related Publications (2)
Darai E, Dubernard G, Bats AS, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Ballester M. Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study. Gynecol Oncol. 2015 Jan;136(1):54-9. doi: 10.1016/j.ygyno.2014.09.011. Epub 2014 Oct 22.
PMID: 25450151DERIVEDBallester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.
PMID: 21489874DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emile DARAÏ, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2009
First Posted
September 30, 2009
Study Start
April 1, 2007
Primary Completion
December 1, 2009
Study Completion
October 1, 2011
Last Updated
December 11, 2012
Record last verified: 2012-12