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

NCT02387645CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Medical University of Vienna

Enrollment

80

Start Date

2014-05-01

Completion Date

2017-05-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Lavage of the Uterus

Conditions

Cancer of EndometriumCarcinoma of EndometriumEndometrial Neoplasms

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

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

Exclusion Criteria:

* pregnant
* incapacitated persons

Outcome Measures

Primary Outcomes

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

Time frame: 10 minutes

Locations

Medical University Vienna, Dptm. of Obstetrics & Gynaecology, Vienna, Austria

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

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