|- candidate number||15793|
|- NTR Number||NTR4299|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-nov-2013|
|- Secondary IDs||NL45143.091.13 |
|- Public Title||Detecting endometrial and ovarian cancer with the Pap-smear
|- Scientific Title||Feasibility of using the Pap-smear as a screening device for the detection of endometrial and ovarian cancer|
|- ACRONYM||DISCOVER: DIagnostig Smear of the Cervix in OVarian and Endometrial canceR|
|- hypothesis||It is possible to detect altered DNA from endometrial and ovarian cancer cells in the Pap-smear by analysing a set of predetermined genes|
|- Healt Condition(s) or Problem(s) studied||Endometrial carcinoma, Ovarian cancer, Cervical cancer, Pap-smear|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2014|
|- planned closingdate||31-dec-2014|
|- Target number of participants||150|
|- Interventions||Cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy|
|- 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
|- Timepoints||T0: Preoperative collection of the cervicovaginal self-sample, Pap-smear and Pipelle endometrial biopsy|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. L. Putten, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. L.F.A.G. Massuger|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Ruby and Rose Foundation|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||29-nov-2013 - 27-mrt-2014|