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ClinicalTrials.gov ID

NCT02545348

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Dec 16, 2019Actual

Start Date

Aug 2015

Primary Completion Date

Aug 2020Estimated

Completion Date

Sep 2020Estimated

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

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.

• Cancer of Endometrium

• Sentinel Lymph Node Biopsy

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Mathieu.JOURET@chwapi.be