PIpelle Prospective @entity1204 (PIPENDO) study, pre-operative recognition of high risk XXXX : a multicentre prospective cohort study.

@entity1204 @entity1 @entity6756 @entity986 @entity7373 @entity876 @entity3546 @entity983 @entity21526 @entity10161
BACKGROUND: @entity1204 is the most common gynaecologic malignancy in industrialised countries and the incidence is still rising. Primary treatment is based on preoperative risk classification and consists in most cases of hysterectomy with bilateral salpingo-oophorectomy. In @entity1 with serous and clear cell histology a complete surgical staging is mandatory. However, in routine clinical practice final histology regularly does not correspond with the preoperative histological diagnosis. This results in both over and under treatment. METHODS/DESIGN: The aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of @entity1204 in order to identify those @entity1 that need extended surgery and/or additional treatment. Additionally, we will determine whether incorporation of cervical cytology and comorbidity could improve this preoperative risk classification. All @entity1 treated for @entity1204 in the participating hospitals from September 2011 till December 2013 are included. @entity1 characteristics, as well as comorbidity are registered. @entity1 without preoperative histology, history of hysterectomy and/or @entity1204 or no surgical treatment including hysterectomy are excluded. The preoperative histology and final pathology will be reviewed and compared by expert pathologists. Additional immunohistochemical analysis of @entity21526 , @entity876 , ER, PR, @entity6756 , @entity983 , @entity3546 , @entity986 , Ki-67, stathmin, @entity10161 and @entity7373 will be performed. Preoperative histology will be compared with the final pathology results. Follow-up will be at least 24  months to determine risk factors for recurrence and outcome. DISCUSSION: This study is designed to improve surgical treatment of @entity1204 @entity1 . A total of 432 @entity1204 @entity1 were enrolled between 2011 and 2013. Follow-up will be completed in 2015. Preoperative histology will be evaluated systematically and background endometrium will be classified. This is the first study incorporating immunohistochemistry, cervical cytology and comorbidity to define the optimal panel of prognostic biomarkers that contribute in clinical decision making in the management of @entity1204 . TRIAL REGISTRATION: Netherlands Trial Register number NTR3503.
