Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes. (LUDOC)

Medical University of Vienna

Status: Completed

Conditions: Ovarian Epithelial Cancer

Treatments: Procedure: Liquid-PAP smear; Procedure: Lavage of the Cavum uteri and proximal fallopian tubes

Study type: Interventional

Funder types: Other

Identifiers

NCT02062697

EK 1148/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• suspected ovarian cancer
• verified ovarian cancer

Exclusion criteria

• pregnant
• incapacitated persons

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ovarian Epithelial Cancer

Other group

Description:

* Lavage of the Cavum uteri and proximal fallopian tubes * Liquid-PAP (Papanicolaou) smear

Treatment:

Procedure: Liquid-PAP smear

Procedure: Lavage of the Cavum uteri and proximal fallopian tubes