Clinical trial NCT02062697: Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.
Official title: Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes - LUDOC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Epithelial Cancer
Keywords: Neoplasms
Glandular and Epithelial
Ovarian Neoplasms
Ovarian cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* suspected ovarian cancer
* verified ovarian cancer

Exclusion Criteria:

* pregnant
* incapacitated persons

Primary outcomes:
measure: Detection of EOCs by mutation analysis in the lavage of the uterine cavity.
timeFrame: Day 1
Secondary outcomes:
measure: Detection of EOCs by mutation analysis of the liquid-based Pap smear.
timeFrame: Day 1
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Dptm. of Obstetrics & Gynaecology
city: Leuven
country: Belgium
facility: University Hospitals Leuven - Department of Obstetrics and Gynaecology
city: Pilsen
country: Czechia
facility: Charles University, Pilsen - Medical Faculty Hospital, Department of Obstetrics and Gynecology
state: Plzeň Region
city: Berlin
country: Germany
facility: Charité University - Campus Virchow Clinic
city: Essen
country: Germany
facility: Klinik Essen Mitte (KEM)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
Study officials:
affiliation: Medical University Vienna, Dptm. of Obstetrics & Gynaecology
name: Paul Speiser, Univ.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: