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

Ovarian Epithelial Cancer Clinical Trial

— LUDOC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062697
• Other study ID #: EK 1148/2011
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: November 2018

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• suspected ovarian cancer

• verified ovarian cancer

Exclusion Criteria:

• pregnant

• incapacitated persons

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Epithelial Cancer
• Precancerous Conditions

Intervention

Procedure:
• Lavage of the Cavum uteri and proximal fallopian tubes

• Liquid-PAP smear

Locations

Country	Name	City	State
Austria	Medical University Vienna, Dptm. of Obstetrics & Gynaecology	Vienna
Belgium	University Hospitals Leuven - Department of Obstetrics and Gynaecology	Leuven
Czechia	Charles University, Pilsen - Medical Faculty Hospital, Department of Obstetrics and Gynecology	Pilsen	Plzen Region
Germany	Charité University - Campus Virchow Clinic	Berlin
Germany	Klinik Essen Mitte (KEM)	Essen
Germany	Universitätsklinikum Hamburg-Eppendorf (UKE)	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1