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

NCT02387645 | Completed

• 1 other identifier: EK1237/2014
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Endometrium; Carcinoma of Endometrium; Endometrial Neoplasms

Keywords

Endometrium; Endometrial Neoplasms; Early detection; Carcinoma of Endometrium; Gynaecological Cancer

Outcome Measures

Primary Outcomes (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.

  preoperative

  10 minutes

Study Arms (1)

Patients prior to surgery for EC/suspicion

EXPERIMENTAL

Patient undergoing surgery for strong suspicion of EC

Procedure: Lavage of the Uterus

Interventions

Lavage of the Uterus PROCEDURE

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.

Patients prior to surgery for EC/suspicion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant
• incapacitated persons

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Paul Speiser, Prof. Dr. med.

  Medical University Vienna, Dptm. of Obstetrics & Gynaecology

  STUDY CHAIR

• Elisabeth Maritschnegg, MSc.

  Medical University Vienna, Dptm. of Obstetrics & Gynaecology

  STUDY CHAIR

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: Professor Dr. (M.D.)

Study Record Dates

• First Submitted: March 8, 2015
• First Posted: March 13, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

AU (1)