An interventional study of Lavage of the Cavum uteri and proximal fallopian tubes and Liquid-PAP smear in Ovarian Epithelial Cancer, sponsored by Medical University of Vienna. Completed at 6 sites in 4 countries. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic
Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.
State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
Aim of this study:
There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.
1,617 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 246 are open to participants now.
This study's enrollment of 50 is close to the median of 47 across 1,194 interventional studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Lavage of the Cavum uteri and proximal fallopian tubes * Liquid-PAP (Papanicolaou) smear
Procedure: Lavage of the Cavum uteri and proximal fallopian tubes · Procedure: Liquid-PAP smear
Also known as: MF 13005 (MADICOPLAST Catheter)
Detection of EOCs by mutation analysis in the lavage of the uterine cavity.
If the adnexal tumor removed turns out to be an EOC, mutation analysis will be carried out applying the sensitive massively parallel sequencing method published by Kinde et al. Mutations in the following genes will be analysed: AKT1, APC, ARID1A, BRAF, CTNNB1, CSMD3, CDKN2A, EGFR, FBXW7, FAT3, FGFR2, KRAS, MLL2, NRAS, PTEN, PIK3CA, PIK3R1, PPP2R1A, PIK3R, RNF43, and TP53.
Time frame: Day 1
Detection of EOCs by mutation analysis of the liquid-based Pap smear.
Obtaining material from the uterine cervix by applying a liquid-based Pap smear technique to directly compare the two sampling techniques - Lavage and liquid-based Pap.
Time frame: Day 1
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Ovarian Epithelial→
Medical University of Vienna