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Sentinel Node and Endometrial Cancer

NCT ID: NCT00987051

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Endometrial Neoplasms

Keywords

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sentinel node procedure radiocolloid patent blue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Patients with endometrial cancer

Group Type EXPERIMENTAL

Detection of sentinel node

Intervention Type PROCEDURE

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

Interventions

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Detection of sentinel node

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emile DARAÏ, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Tenon Hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25450151 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21489874 (View on PubMed)

Other Identifiers

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P060229

Identifier Type: -

Identifier Source: org_study_id