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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02062697

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Epithelial Cancer	Procedure: Lavage of the Cavum uteri and proximal fallopian tubes Procedure: Liquid-PAP smear	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Ovarian Epithelial Cancer Lavage of the Cavum uteri and proximal fallopian tubes Liquid-PAP (Papanicolaou) smear	Procedure: Lavage of the Cavum uteri and proximal fallopian tubes Other Names: MF 13005 (MADICOPLAST Catheter) Procedure: Liquid-PAP smear

Arm

Intervention/Treatment

Other: Ovarian Epithelial Cancer

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

Procedure: Lavage of the Cavum uteri and proximal fallopian tubes

Other Names:

MF 13005 (MADICOPLAST Catheter)

Procedure: Liquid-PAP smear

Outcome Measures

Primary Outcome Measures

Detection of EOCs by mutation analysis in the lavage of the uterine cavity. [Day 1]
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.

Secondary Outcome Measures

Detection of EOCs by mutation analysis of the liquid-based Pap smear. [Day 1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

suspected ovarian cancer
verified ovarian cancer

Exclusion Criteria:

pregnant
incapacitated persons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Vienna, Dptm. of Obstetrics & Gynaecology	Vienna		Austria	1090
2	University Hospitals Leuven - Department of Obstetrics and Gynaecology	Leuven		Belgium	3000
3	Charles University, Pilsen - Medical Faculty Hospital, Department of Obstetrics and Gynecology	Pilsen	Plzeň Region	Czechia	301 66
4	Charité University - Campus Virchow Clinic	Berlin		Germany	13353
5	Klinik Essen Mitte (KEM)	Essen		Germany	92 45136
6	Universitätsklinikum Hamburg-Eppendorf (UKE)	Hamburg		Germany	20246