No registrations found.
ID
Source
Brief title
Health condition
Endometrial cancer
Ovarian cancer
Endometriumcarcinoom
Ovariumcarcinoom
Eierstokkanker
Baarmoederslijmvlieskanker
Pap-smear
Uitstrijkje
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of the Pap-smear in detecting endometrial and ovarian cancer
Secondary outcome
The sensitivity and specificity of the cervicovaginal self-sample and the Pipelle endometrial biopsy in detecting endometrial and ovarian cancer.
The correlation between DNA alterations in the cervicovaginal self-sample, the Pap-smear and the Pipelle endometrial biopsy and clinicopathologic parameters
Background summary
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.
Study objective
It is possible to detect altered DNA from endometrial and ovarian cancer cells in the Pap-smear by analysing a set of predetermined genes
Study design
T0: Preoperative collection of the cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy
Intervention
Cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy
L. Putten, van der
Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443690
l.vanderputten@vumc.nl
L. Putten, van der
Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443690
l.vanderputten@vumc.nl
Inclusion criteria
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.
Exclusion criteria
Patients who received pelvic radiation in the past and patients with ovarian cancer who do not have a uterus will not be able to participate in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4031 |
| NTR-old | NTR4299 |
| CCMO | NL45143.091.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39020 |