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Sentinel Node and Endometrial Cancer (Senti-Endo)

Primary Purpose

Endometrial Neoplasms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Detection of sentinel node
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Neoplasms focused on measuring sentinel node procedure, radiocolloid, patent blue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Tenon Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Patients with endometrial cancer

Outcomes

Primary Outcome Measures

Detection and false negative rates of sentinel node

Secondary Outcome Measures

Morbidity and recurrence rates

Full Information

First Posted
July 30, 2009
Last Updated
December 10, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00987051
Brief Title
Sentinel Node and Endometrial Cancer
Acronym
Senti-Endo
Official Title
Validation of the Sentinel Node in Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms
Keywords
sentinel node procedure, radiocolloid, patent blue

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients with endometrial cancer
Intervention Type
Procedure
Intervention Name(s)
Detection of sentinel node
Intervention Description
Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection
Primary Outcome Measure Information:
Title
Detection and false negative rates of sentinel node
Time Frame
During the surgery (hysterectomy)
Secondary Outcome Measure Information:
Title
Morbidity and recurrence rates
Time Frame
During 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emile DARAÏ, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tenon Hospital
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25450151
Citation
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.
Results Reference
derived
PubMed Identifier
21489874
Citation
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.
Results Reference
derived

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Sentinel Node and Endometrial Cancer

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