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

NCT02062697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-25

No results posted yet for this study

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

Interventions

PROCEDURE

Lavage of the Cavum uteri and proximal fallopian tubes

PROCEDURE

Liquid-PAP smear

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Paul Speiser, Univ.Prof.Dr. · Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062697 on ClinicalTrials.gov