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Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma

NCT02039388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2022-09-02

No results posted yet for this study

Summary

The current study aims at answering the scientific question, whether exfoliated cells from STICs get transported into the uterine cavity via the fallopian tube, and whether it is possible to detect those cells in the lavage fluid from the uterine cavity and proximal fallopian tubes.

To address this question, the investigators will study 20 lavage samples and their 20 corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.

Conditions

Interventions

PROCEDURE

Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Paul Speiser, Univ.Prof.Dr.med. · 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
2013-11-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Ireland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02039388 on ClinicalTrials.gov