Use of the Sentinel Node Biopsy for Early Endometrial Cancer. (SNE)

December 13, 2019 updated by: Luyckx, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
      • Brussel, Belgium, 1180
        • Recruiting
        • Cliniques de l'Europe
        • Contact:
        • Contact:
          • Alain Charles
      • Brussel, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Charleroi, Belgium, 6000
        • Not yet recruiting
        • GHdC
        • Contact:
          • Timour Willems
      • Liège, Belgium, 6000
      • Ottignies, Belgium, 1340
      • Tournai, Belgium, 7500
    • Hainaut
      • Mons, Hainaut, Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All the patient with early stage endometrial cancer, whith or without indication of complete lymphadenectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of the adjuvant treatement by the information bring by the sentinel node analysis
Time Frame: 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.
5 years
Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.
Time Frame: 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.
5 years
False positive rate of the frozen section analysis
Time Frame: 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
5 years
False negative rate of the sentinel node, after frosen section analyse and the complete analysis
Time Frame: 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.
5 years
Early and late complications of the procedure
Time Frame: 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,...)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Luyckc Luyckx, Cliniques Universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StLucGsendo1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of Endometrium

Clinical Trials on Sentinel Lymph Node Biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe