PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study

BMC Cancer

Study Protocol

Harrie W. H. Feijen¹  Marc P. M. L. Snijders²  Ingrid Vandenput³  Joke E. Haartsen⁴  Brenda M. Pijlman⁵  Erik A. Boss⁶  Leon F.A.G. Massuger⁷  M. Caroline Vos⁸  Johanna M. A. Pijnenborg⁹  Peter E. J. de Wit^1,10  Ineke M. de Kievit^1,11  Hilde A. D. M. van Herk^1,12  Carolien M. Bronkhorst^1,13  Paul J. J. M. Klinkhamer^1,14  Nicole C. M. Visser^1,15  Johan Bulten^1,15  Anneke A. M. van der Wurff^1,16  Lonneke V. van de Poll-Franse^1,17 

[1] Dept. Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands;Dept. Obstetrics and Gynaecology, Canisius Wilhemina Hospital, Nijmegen, The Netherlands;Dept. Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands;Dept. Obstetrics and Gynaecology, Elkerliek Hospital, Helmond, The Netherlands;Dept. Obstetrics and Gynaecology, Jeroen Bosch Hospital, ′s-Hertogenbosch, The Netherlands;Dept. Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven and Eindhoven, The Netherlands;Dept. Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, The Netherlands;Dept. Obstetrics and Gynaecology, St Elisabeth Hospital, Tilburg, The Netherlands;Dept. Obstetrics and Gynaecology, TweeSteden Hospital, Tilburg, The Netherlands;Dept. Pathology, Amphia Hospital, Breda, The Netherlands;Dept. Pathology, Canisius Wilhemina Hospital, Nijmegen, The Netherlands;Dept. Pathology, Elkerliek Hospital, Helmond, The Netherlands;Dept. Pathology, Jeroen Bosch Hospital, ′s-Hertogenbosch, The Netherlands;Dept. Pathology, PAMM, Eindhoven, The Netherlands;Dept. Pathology, Radboud university medical centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands;Dept. Pathology, St Elisabeth Hospital, Tilburg, The Netherlands;Dept. of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands;Comprehensive Cancer Centre the Netherlands, Eindhoven, The Netherlands;

关键词: Endometrial carcinoma;    Histological diagnosis;    Endometrial sampling;    Postmenopausal bleeding;    Observational cohort study;    Risk assessment;   

DOI  :  10.1186/s12885-015-1487-3

 received in 2014-11-07, accepted in 2015-06-10,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundEndometrial carcinoma 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 patients 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/DesignThe aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of endometrial carcinoma in order to identify those patients 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 patients treated for endometrial carcinoma in the participating hospitals from September 2011 till December 2013 are included. Patient characteristics, as well as comorbidity are registered. Patients without preoperative histology, history of hysterectomy and/or endometrial carcinoma 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 IMP3, p53, ER, PR, MLH1, PTEN, beta-catenin, p16, Ki-67, stathmin, ARID1A and L1CAM 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.DiscussionThis study is designed to improve surgical treatment of endometrial carcinoma patients. A total of 432 endometrial carcinoma patients 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 endometrial carcinoma.Trial registrationNetherlands Trial Register number NTR3503

【 授权许可】

CC BY   
© Visser et al. 2015