Sentinel Node and Endometrial Cancer (Senti-Endo)
December 10, 2012 updated by: Assistance Publique - Hôpitaux de Paris
Validation of the Sentinel Node in Endometrial Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75020
- Tenon Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Patients with endometrial cancer
|
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Detection and false negative rates of sentinel node
Time Frame: During the surgery (hysterectomy)
|
During the surgery (hysterectomy)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Morbidity and recurrence rates
Time Frame: During 24 months
|
During 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emile DARAÏ, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Ballester 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
July 30, 2009
First Submitted That Met QC Criteria
September 29, 2009
First Posted (ESTIMATE)
September 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 11, 2012
Last Update Submitted That Met QC Criteria
December 10, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P060229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.