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Use of the Sentinel Node Biopsy for Early Endometrial Cancer.

NCT ID: NCT02545348

Last Updated: 2019-12-16

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-09-30

Brief Summary

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This is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. The collaborating centres with the OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc will also particpate to the trial.

Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading team in the world published very good result and that the first prospectives trials are already published with also excellents results. The investigators decided then to include this practice in their institutional guideslines and also to registred the procedure.

Detailed Description

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All the sentinel node biopsy procedures for endometrial cancer will be record online via the REDCap tools, securized on a servor in Saint-Luc. Automatic email for the following of the patients and the post operative event will be send regularly for every patient to the physicians who include the patient. Efficacy of the technique, False negative and postive rate, modifications of the adjuvant treatement, long terme evolution and complication wil be evaluate.

Conditions

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Cancer of Endometrium

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Sentinel Lymph Node Biopsy

First, the detection of the sentinel node will be preformed at the beginning of the surgery. Differents detection methods are use and the efficacy of each will be recorded. Second, dissection and extraction of the sentinel node will be performed, to send it to the frozen section examination. Third, other lymph node could be removed if the surgeon evaluate that it is feasible and necessary. In this group, the false negative rate will be also evaluate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Endometrial cancer early stage on the pre operative examinations
* Performance status that allow a surgery
* Surgery by laparoscopy or laparotomy

Exclusion Criteria

* Patient already operated of the hysterectomy who need lymphatic restadification
* Stage IV disease
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Luyckx

Assistant Chief Resident - Gynecologic Oncology - King Albert Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luyckc Luyckx

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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CHU AMbroise Parée

Mons, Hainaut, Belgium

Site Status RECRUITING

Cliniques de l'Europe

Brussels, , Belgium

Site Status RECRUITING

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Clinique St Jean

Brussels, , Belgium

Site Status RECRUITING

Cliniques Saint-Anne - Saint Remi

Brussels, , Belgium

Site Status RECRUITING

Hôpital d'Ixelles

Brussels, , Belgium

Site Status RECRUITING

GHDC

Charleroi, , Belgium

Site Status NOT_YET_RECRUITING

Université de Liège

Liège, , Belgium

Site Status RECRUITING

Cliniques Saint-Pierre Ottignies

Ottignies, , Belgium

Site Status RECRUITING

CHWaPi

Tournai, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Mathieu LUYCKX

Role: CONTACT

Phone: 27649509

Email: [email protected]

Jean-Luc Squifflet

Role: CONTACT

Phone: 27649501

Email: [email protected]

Facility Contacts

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Kurt Crener, MD

Role: primary

Marc Waterkeyn

Role: primary

Alain Charles

Role: backup

Mathieu Luyckx

Role: primary

Jean-Luc Squifflet

Role: backup

Jean-Paul Van gossum, MD

Role: primary

Bruno Vandermeersch, MD

Role: primary

Frédéric BUXANT, MD

Role: primary

Timour Willems

Role: primary

Frédéric Kridelka, PhD

Role: primary

Vincent Malvaux

Role: primary

Mathieu Jouret

Role: primary

Marc Wayemberg

Role: backup

Other Identifiers

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StLucGsendo1

Identifier Type: -

Identifier Source: org_study_id