Clinical trial NCT02545348: Use of the Sentinel Node Biopsy for Early Endometrial Cancer.
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Endometrium
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patient with early stage endometrial cancer, whith or without indication of complete lymphadenectomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
timeFrame: 5 years
Secondary outcomes:
measure: Modification of the adjuvant treatement by the information bring by the sentinel node analysis
timeFrame: 5 years
measure: Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.
timeFrame: 5 years
measure: False positive rate of the frozen section analysis
timeFrame: 5 years
measure: False negative rate of the sentinel node, after frosen section analyse and the complete analysis
timeFrame: 5 years
measure: Early and late complications of the procedure
timeFrame: 5 years
Other outcomes:
Locations:
city: Mons
country: Belgium
facility: CHU AMbroise Parée
state: Hainaut
city: Brussel
country: Belgium
facility: Cliniques de l'Europe
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Clinique St Jean
city: Brussel
country: Belgium
facility: Hôpital d'Ixelles
city: Bruxelles
country: Belgium
facility: Cliniques Saint-Anne - Saint Remi
city: Charleroi
country: Belgium
facility: GHDC
city: Liège
country: Belgium
facility: Université de Liège
city: Ottignies
country: Belgium
facility: Cliniques Saint-Pierre Ottignies
city: Tournai
country: Belgium
facility: CHWaPi
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Luyckc Luyckx
role: PRINCIPAL_INVESTIGATOR
References: