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LUDEC Study - Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Endometrial Carcinoma (LUDEC)

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ClinicalTrials.gov Identifier: NCT02387645
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna

Brief Summary:
The current pilot study aims at answering the scientific question, whether exfoliated cells from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based cervical cytology. If this turns out to be the case, earlier detection, particularly of type II EC should be possible.

Condition or disease Intervention/treatment Phase
Cancer of Endometrium Carcinoma of Endometrium Endometrial Neoplasms Procedure: Lavage of the Uterus Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: LUDEC Study - Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Endometrial Carcinoma
Study Start Date : May 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Patients prior to surgery for EC/suspicion
Patient undergoing surgery for strong suspicion of EC
Procedure: Lavage of the Uterus
The lavage will be performed in the operating theatre under general anesthesia. The ALPINE technique includes the following steps. A three way catheter (catheter for uterine and tubal lavage) is inserted into the cervical canal and a balloon is inflated to seal the cervical canal. The patient is put into anti-Trendellenburg positioning. Normal saline is slowly flushed into the uterine cavity and proximal tubes. After the lavage is finished, the balloon is deflated and the catheter is removed. A cap is put on the collection syringe and the syringe is sent to the laboratory.




Primary Outcome Measures :
  1. Detection of EC with a very high sensitivity and specifisity - by mutation analysis of cell material gained through the lavage of the uterine cavity and fallopian tubes. [ Time Frame: 10 minutes ]
    preoperative



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing "dilation and curettage" and hysteroscopy for abnormal uterine bleeding
  • Patients undergoing hysterectomy for EC

Exclusion Criteria:

  • pregnant
  • incapacitated persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387645


Locations
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Austria
Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Paul Speiser, Prof. Dr. med. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Study Chair: Elisabeth Maritschnegg, MSc. Medical University Vienna, Dptm. of Obstetrics & Gynaecology

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Responsible Party: Paul Speiser, Prof.MD,, Professor Dr. (M.D.), Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02387645     History of Changes
Other Study ID Numbers: EK1237/2014
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Keywords provided by Paul Speiser, Prof.MD,, Medical University of Vienna:
Endometrium
Endometrial Neoplasms
Early detection
Carcinoma of Endometrium
Gynaecological Cancer
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female