Use of the Sentinel Node Biopsy for Early Endometrial Cancer.

Cancer of Endometrium Clinical Trial

— SNE  

Official title:

Evaluation (Good Medical Practice Evaluation) of the Use of the Sentinel Node Biopsy in Early Stage Endometrial Cancer and Its Implication on the Adjuvant Treatement and on the Outcomes of the Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545348
• Other study ID #: StLucGsendo1
• Status: Recruiting
• Start date: August 2015
• Est. completion date: September 2020

Study information

• Verified date: December 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Mathieu LUYCKX
• Phone: 27649509
• Email: mathieu.luyckx[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Endometrium
• Endometrial Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Clinique St Jean	Brussel
Belgium	Cliniques de l'Europe	Brussel
Belgium	Cliniques universitaires Saint-Luc	Brussel
Belgium	Hôpital d'Ixelles	Brussel
Belgium	Cliniques Saint-Anne - Saint Remi	Bruxelles
Belgium	GHDC	Charleroi
Belgium	Université de Liège	Liège
Belgium	CHU AMbroise Parée	Mons	Hainaut
Belgium	Cliniques Saint-Pierre Ottignies	Ottignies
Belgium	CHWaPi	Tournai

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators	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	5 years
Secondary	Modification of the adjuvant treatement by the information bring by the sentinel node analysis	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.	5 years
Secondary	Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.	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.	5 years
Secondary	False positive rate of the frozen section analysis	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	5 years
Secondary	False negative rate of the sentinel node, after frosen section analyse and the complete analysis	In the group of patient who underwent a complet lymphadenectomy, a false negative rate will be calculate, with a expected number really low.	5 years
Secondary	Early and late complications of the procedure	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,...)	5 years