title: PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study.
abstract: BACKGROUND
  Endometrial 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
  The 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Netherlands Trial Register number NTR3503.
authors.affiliation: Dept. Pathology, Radboud university medical centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. nicole.visser@radboudumc.nl.
authors.forename: Nicole C M
authors.initials: NC
authors.lastname: Visser
authors.affiliation: Dept. Pathology, Radboud university medical centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. Hans.Bulten@radboudumc.nl.
authors.forename: Johan
authors.initials: J
authors.lastname: Bulten
authors.affiliation: Dept. Pathology, St Elisabeth Hospital, Tilburg, The Netherlands. a.vd.wurff@elisabeth.nl.
authors.forename: Anneke A M
authors.initials: AA
authors.lastname: van der Wurff
authors.affiliation: Dept. Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven and Eindhoven, The Netherlands. e.boss@mmc.nl.
authors.forename: Erik A
authors.initials: EA
authors.lastname: Boss
authors.affiliation: Dept. Pathology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. c.bronkhorst@jbz.nl.
authors.forename: Carolien M
authors.initials: CM
authors.lastname: Bronkhorst
authors.affiliation: Dept. Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands. HFeijen@Amphia.nl.
authors.forename: Harrie W H
authors.initials: HW
authors.lastname: Feijen
authors.affiliation: Dept. Obstetrics and Gynaecology, Elkerliek Hospital, Helmond, The Netherlands. jhaartsen@elkerliek.nl.
authors.forename: Joke E
authors.initials: JE
authors.lastname: Haartsen
authors.affiliation: Dept. Pathology, Elkerliek Hospital, Helmond, The Netherlands. hvherk@elkerliek.nl.
authors.forename: Hilde A D M
authors.initials: HA
authors.lastname: van Herk
authors.affiliation: Dept. Pathology, Canisius Wilhemina Hospital, Nijmegen, The Netherlands. i.d.kievit@cwz.nl.
authors.forename: Ineke M
authors.initials: IM
authors.lastname: de Kievit
authors.affiliation: Dept. Pathology, PAMM, Eindhoven, The Netherlands. P.Klinkhamer@pamm.nl.
authors.forename: Paul J J M
authors.initials: PJ
authors.lastname: Klinkhamer
authors.affiliation: Dept. Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. B.Pijlman@jbz.nl.
authors.forename: Brenda M
authors.initials: BM
authors.lastname: Pijlman
authors.affiliation: Dept. Obstetrics and Gynaecology, Canisius Wilhemina Hospital, Nijmegen, The Netherlands. m.snijders@cwz.nl.
authors.forename: Marc P M L
authors.initials: MP
authors.lastname: Snijders
authors.affiliation: Dept. Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands. ingrid.vandenput@catharinaziekenhuis.nl.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Vandenput
authors.affiliation: Dept. Obstetrics and Gynaecology, St Elisabeth Hospital, Tilburg, The Netherlands. c.vos@elisabeth.nl.
authors.forename: M Caroline
authors.initials: MC
authors.lastname: Vos
authors.affiliation: Dept. Pathology, Amphia Hospital, Breda, The Netherlands. pdwit@amphia.nl.
authors.forename: Peter E J
authors.initials: PE
authors.lastname: de Wit
authors.affiliation: Dept. of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. L.vd.Poll@ikz.nl.|Comprehensive Cancer Centre the Netherlands, Eindhoven, The Netherlands. L.vd.Poll@ikz.nl.
authors.forename: Lonneke V
authors.initials: LV
authors.lastname: van de Poll-Franse
authors.affiliation: Dept. Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, The Netherlands. Leon.Massuger@radboudumc.nl.
authors.forename: Leon F A G
authors.initials: LF
authors.lastname: Massuger
authors.affiliation: Dept. Obstetrics and Gynaecology, TweeSteden Hospital, Tilburg, The Netherlands. hpijnenborg@tsz.nl.
authors.forename: Johanna M A
authors.initials: JM
authors.lastname: Pijnenborg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D015331:Cohort Studies; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000453:epidemiology / Q000235:genetics / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000096:biosynthesis* / Q000235:genetics; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000235:genetics / Q000473:pathology* / Q000601:surgery; D011379:Prognosis; D011446:Prospective Studies
chemical_list: D009363:Neoplasm Proteins