Use of the Sentinel Node Biopsy for Early Endometrial Cancer.

• Conditions: Cancer of Endometrium

• Registration Number: NCT02545348
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16
• Primary Completion: 2020-08
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators	5 years	Each hemi pelvis is count as an unit for the detection rate, but also the detection per patient will be calculated. For a positive detection with the patient as an unit, the detection must be bilateral

Secondary Outcome Measures

Name	Time	Method
Modification of the adjuvant treatement by the information bring by the sentinel node analysis	5 years	An evaluation of the modification of the adjuvant treatement by the results of the node sentinel will be performed, in case of it was performed alone and then compared to the guides lines when no information on the nodal status is knowed. It will also be evaluated in cas where a complete lymphadenectomy was performed to evaluate the interest of the ultrastaging on the sentinel node.
Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.	5 years	Influence of the use of the sentinel node only or in addition to the complete lymphadenectomy on the DFS and the OS by comparing with the litterature accorded DFS and OS will be evaluate. Type of reccurence will also be attentively observed, in order to ensure the safety of the sentinel node dissection only. If the technique is reliable, the rate of nodal reccurence after negative sentinel node should be low.
False positive rate of the frozen section analysis	5 years	Each negative sentinel node at the frozen section analyse wil also undergo a second analysis after "calssical" preparation of the tissue and alos immunochemestry analysis
False negative rate of the sentinel node, after frosen section analyse and the complete analysis	5 years	In the group of patient who underwent a complet lymphadenectomy, a false negative rate will be calculate, with a expected number really low.
Early and late complications of the procedure	5 years	Per operative, early and late post operative complication related to the sentinel node procedure will be recorded in the REDCap file, and will be compared to the group of complete lymphadenectomy, with a special focus on lymphatics complications (lymphocyst, lymphoedema,...)

Trial Locations

Locations (10)

GHDC; 🇧🇪 Charleroi, Belgium

Cliniques Saint-Pierre Ottignies; 🇧🇪 Ottignies, Belgium

CHU AMbroise Parée; 🇧🇪 Mons, Hainaut, Belgium

Hôpital d'Ixelles; 🇧🇪 Brussel, Belgium

Cliniques Saint-Anne - Saint Remi; 🇧🇪 Bruxelles, Belgium

Clinique St Jean; 🇧🇪 Brussel, Belgium

Université de Liège; 🇧🇪 Liège, Belgium

Cliniques de l'Europe; 🇧🇪 Brussel, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Brussel, Belgium

CHWaPi; 🇧🇪 Tournai, Belgium