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

NCT02062697 | Completed

• 1 other identifier: EK 1148/2011
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 6

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.

Conditions

Ovarian Epithelial Cancer

Keywords

Neoplasms; Glandular and Epithelial; Ovarian Neoplasms; Ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection of EOCs by mutation analysis of the liquid-based Pap smear.

  Day 1

Study Arms (1)

Ovarian Epithelial Cancer

OTHER

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

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

Interventions

Lavage of the Cavum uteri and proximal fallopian tubes PROCEDURE

Also known as: MF 13005 (MADICOPLAST Catheter)

Ovarian Epithelial Cancer

Liquid-PAP smear PROCEDURE

Ovarian Epithelial Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspected ovarian cancer
• verified ovarian cancer

You may not qualify if:

• pregnant
• incapacitated persons

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (6)

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, 1090, Austria

Location

University Hospitals Leuven - Department of Obstetrics and Gynaecology

Leuven, 3000, Belgium

Location

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

Pilsen, Plzeň Region, 301 66, Czechia

Location

Charité University - Campus Virchow Clinic

Berlin, 13353, Germany

Location

Klinik Essen Mitte (KEM)

Essen, 92 45136, Germany

Location

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Paul Speiser, Univ.Prof.Dr.

  Medical University Vienna, Dptm. of Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof.MD.

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: February 14, 2014
• Study Start: February 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

AU (1); CZ (1); BE (1); DE (3)