Visser Nicole C M, Bulten Johan, van der Wurff Anneke A M, Boss Erik A, Bronkhorst Carolien M, Feijen Harrie W H, Haartsen Joke E, van Herk Hilde A D M, de Kievit Ineke M, Klinkhamer Paul J J M, Pijlman Brenda M, Snijders Marc P M L, Vandenput Ingrid, Vos M Caroline, de Wit Peter E J, van de Poll-Franse Lonneke V, Massuger Leon F A G, Pijnenborg Johanna M A
Dept. Pathology, Radboud university medical centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.
Dept. Pathology, St Elisabeth Hospital, Tilburg, The Netherlands.
BMC Cancer. 2015 Jun 30;15:487. doi: 10.1186/s12885-015-1487-3.
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/DESIGN: 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.
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.
Netherlands Trial Register number NTR3503.
子宫内膜癌是工业化国家最常见的妇科恶性肿瘤，且发病率仍在上升。主要治疗方法基于术前风险分类，多数情况下包括子宫切除术及双侧输卵管卵巢切除术。对于浆液性和透明细胞组织学类型的患者，必须进行完整的手术分期。然而，在常规临床实践中，最终组织学结果常常与术前组织学诊断不符。这导致了治疗过度和治疗不足的情况。
方法/设计：这项多中心前瞻性队列研究的目的是选择一组预后生物标志物，以改善子宫内膜癌的术前诊断，从而识别那些需要扩大手术范围和/或额外治疗的患者。此外，我们将确定纳入宫颈细胞学检查和合并症是否能改善这种术前风险分类。纳入2011年9月至2013年12月期间在参与医院接受子宫内膜癌治疗的所有患者。记录患者特征以及合并症情况。排除术前无组织学检查结果、有子宫切除术和/或子宫内膜癌病史或未接受包括子宫切除术在内的手术治疗的患者。术前组织学和最终病理结果将由专家病理学家进行复查和比较。将对IMP3、p53、雌激素受体（ER）、孕激素受体（PR）、错配修复蛋白1（MLH1）、磷酸酶和张力蛋白同源物（PTEN）、β-连环蛋白、p16、Ki-67、微管相关蛋白stathmin、AT丰富结合域1A蛋白（ARID1A）和淋巴细胞抗原L1细胞粘附分子（L1CAM）进行额外的免疫组化分析。将术前组织学与最终病理结果进行比较。随访至少24个月，以确定复发风险因素和预后情况。
本研究旨在改善子宫内膜癌患者的手术治疗。2011年至2013年间共纳入432例子宫内膜癌患者。随访将于2015年完成。将系统评估术前组织学，并对背景子宫内膜进行分类。这是第一项纳入免疫组化、宫颈细胞学检查和合并症来确定有助于子宫内膜癌管理临床决策的最佳预后生物标志物组合的研究。
荷兰试验注册编号NTR3503。
