Detecting endometrial and ovarian cancer with the Pap-smear

Rationale: In 2011, 1257 women in The Netherlands were diagnosed with ovarian cancer and 1913 with endometrial cancer, causing respectively 1043 and 484 deaths. Ovarian cancer has few symptoms in an early stage and is usually diagnosed in an advanced stage, leading to a bad prognosis. Endometrial cancer has a better prognosis, but the incidence is still rising. Earlier detection or even screening for these diseases would help improve survival. Recent developments in DNA analysis might be used to diagnose ovarian and endometrial cancer with a Pap-smear.



Objective: To verify the feasibility of using the Pap-smear in diagnosing endometrial and ovarian cancer.



Study design: Prospective multicentre cohort study.

Study population: Endometrial cancer: all patients presenting with preoperative diagnosis of endometrial cancer (via pipelle endometrial biopsy or dilatation and curettage) . Ovarian cancer: all patients scheduled for surgery for suspected ovarian cancer (RMI>200, ascites). Controls: patients undergoing at least a hysterectomy for benign pathology.



Intervention: Patients with ovarian or endometrial cancer will undergo a Pap-smear and pipelle endometrial sampling. Mutation analysis results will be compared to mutation analysis of the primary tumour as well as a Pap-smear and pipelle endometrial sampling performed in subjects without cancer of the female reproductive tract.



Main study parameters: The main study parameter is the correlation between mutations found in the Pap-smear, cervicovaginal self-sampling and pipelle endometrial sampling and the primary tumour.

It is possible to detect altered DNA from endometrial and ovarian cancer cells in the Pap-smear by analysing a set of predetermined genes

T0: Preoperative collection of the cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy

Cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy