Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.
Condition: Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial; Precancerous Conditions
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lavage of the Cavum uteri and proximal fallopian tubes; Liquid-PAP smear
Intervention type(s): Procedure; Procedure
Other intervention name(s): MF 13005 (MADICOPLAST Catheter)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neoplasms; Glandular and Epithelial; Ovarian Neoplasms; Ovarian cancer