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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrial cancer early stage on the pre operative examinations
- •Performance status that allow a surgery
- •Surgery by laparoscopy or laparotomy
排除标准
- •Patient already operated of the hysterectomy who need lymphatic restadification
- •Stage IV disease
结局指标
主要结局
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
时间窗: 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
次要结局
- 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)
研究者
Luyckx
Assistant Chief Resident - Gynecologic Oncology - King Albert Institute
Cliniques universitaires Saint-Luc- Université Catholique de Louvain