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

NCT ID: NCT02062697

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-11-30

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.

Conditions

Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ovarian Epithelial Cancer

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

Group Type: OTHER

Lavage of the Cavum uteri and proximal fallopian tubes

Intervention Type: PROCEDURE

Liquid-PAP smear

Intervention Type: PROCEDURE

Interventions

Lavage of the Cavum uteri and proximal fallopian tubes

Intervention Type: PROCEDURE

Liquid-PAP smear

Intervention Type: PROCEDURE

Other Intervention Names

MF 13005 (MADICOPLAST Catheter)

Eligibility Criteria

Inclusion Criteria

• suspected ovarian cancer
• verified ovarian cancer

Exclusion Criteria

• pregnant
• incapacitated persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Paul Speiser, Prof.MD,

Univ.Prof.MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Speiser, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Locations

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, , Austria

University Hospitals Leuven - Department of Obstetrics and Gynaecology

Leuven, , Belgium

Charles University, Pilsen - Medical Faculty Hospital, Department of Obstetrics and Gynecology

Pilsen, Plzeň Region, Czechia

Charité University - Campus Virchow Clinic

Berlin, , Germany

Klinik Essen Mitte (KEM)

Essen, , Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, , Germany

Countries

Austria; Belgium; Czechia; Germany

Other Identifiers

EK 1148/2011

Identifier Type: -

Identifier Source: org_study_id