Use of the Sentinel Node Biopsy for Early Endometrial Cancer.

NCT02545348 | Unknown

• 1 other identifier: StLucGsendo1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Cancer of Endometrium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Modification of the adjuvant treatement by the information bring by the sentinel node analysis

  5 years

• Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.

  5 years

• False positive rate of the frozen section analysis

  5 years

• False negative rate of the sentinel node, after frosen section analyse and the complete analysis

  5 years

• Early and late complications of the procedure

  5 years

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Endometrial cancer early stage on the pre operative examinations
• Performance status that allow a surgery
• Surgery by laparoscopy or laparotomy

You may not qualify if:

• Patient already operated of the hysterectomy who need lymphatic restadification
• Stage IV disease

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (10)

CHU AMbroise Parée

Mons, Hainaut, Belgium

RECRUITING

Cliniques de l'Europe

Brussels, 1180, Belgium

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Clinique St Jean

Brussels, Belgium

RECRUITING

Cliniques Saint-Anne - Saint Remi

Brussels, Belgium

RECRUITING

Hôpital d'Ixelles

Brussels, Belgium

RECRUITING

GHDC

Charleroi, 6000, Belgium

NOT YET RECRUITING

Université de Liège

Liège, 6000, Belgium

RECRUITING

Cliniques Saint-Pierre Ottignies

Ottignies, 1340, Belgium

RECRUITING

CHWaPi

Tournai, 7500, Belgium

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Luyckc Luyckx

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu LUYCKX

CONTACT

27649509; mathieu.luyckx@uclouvain.be

Jean-Luc Squifflet

CONTACT

27649501; jean-luc.squifflet@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief Resident - Gynecologic Oncology - King Albert Institute

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 9, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

BE (10)