Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma (LUSTIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02039388
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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, we 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.


Condition Intervention
Ovarian Epithelial Cancer
Carcinoma in Situ
Ovarian Cancer
Procedure: Lavage of the Cavum uteri and proximal Fallopian tubes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Detection of "Serous Tubal Intraepithelial Carcinomas (STICs)" in the lavage fluid from the uterine cavity and proximal fallopian tubes. [ Time Frame: preoperative ] [ Designated as safety issue: No ]
    Women who opt for rrBSO or opt to have the fallopian tubes removed but the ovaries preserved, and women who opt for rrBSO plus hysterectomy. The lavage can be done either in an outpatient setting or in the operating theatre under general anaesthesia.


Estimated Enrollment: 200
Study Start Date: November 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High risk patients for breast and/or ovarian cancer Procedure: Lavage of the Cavum uteri and proximal Fallopian tubes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BRCA1/2 mutation carriers
  • strong family history of breast and/or ovarian cancer suggestive for a germ line mutation in a relevant gene

Exclusion Criteria:

  • pregnant
  • incapacitated persons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039388

Contacts
Contact: Paul Speiser, Univ.Prof.Dr.med. +436765367608 paul.speiser@meduniwien.ac.at
Contact: Nina Pecha, abs.med. +436767168264 nina.pecha@meduniwien.ac.at

Locations
Belgium
Catholic University Leuven - Department of Obstetrics and Gynaecology Recruiting
Leuven, Belgium, 3000
Contact: Ignace Vergote, Prof.Dr.    +32/1634 ext 4208    ignace.vergote@uzleuven.be   
Contact: Joke de Roover    +32 16 34 ext 74 19    joke.deroover@uz.kuleuven.ac.be   
Germany
Charité University - Campus Virchow Chlinic Not yet recruiting
Berlin, Germany, 13353
Contact: Jalid Sehouli, Prof.Dr.med.       Jalid.Sehouli@charite.de   
Contact: Ioana Braicu, Dr.    +49 30 450 564 ext 002    ioana@braicu.de   
Klinik Essen Mitte (KEM) Not yet recruiting
Essen, Germany, 92 45136
Contact: Andreas Du Bois, Prof.Dr.med.    +49 (0) 201 174 ext 34002    a.dubois@kliniken-essen-mitte.de   
Contact: Florian Heitz, Dr.med.    +49 (0) 201 174 ext 34444    f.heitz@kliniken-essen-mitte.de   
Universitätsklinikum Hamburg-Eppendorf (UKE) Not yet recruiting
Hamburg, Germany, 20246
Contact: Sven Mahner, Priv.-Doz. Dr.med.    (040) 7410-23800    s.mahner@uke.de   
Contact: Fabian Trillsch, Dr.med.    (040) 7410-23800    f.trillsch@uke.de   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Paul Speiser, Univ.Prof.Dr.med. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Study Chair: Robert Zeillinger, Univ.Prof.Dr. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Study Chair: Elisabeth Maritschnegg, MSc Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Study Chair: Nina Pecha, abs.med. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
  More Information

No publications provided

Responsible Party: Paul Speiser, Prof.MD,, Univ.Prof.Dr.med., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02039388     History of Changes
Other Study ID Numbers: EK 1766/2013
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Ovarian Epithelial Cancer
Serous Intraepithelial Carcinoma (STIC)
BRCA1 gene
BRCA2 gene
Mutation
Neoplasms
Glandular and Epithelial
Ovarian Neoplasms
Ovarian cancer
Carcinoma in situ
family history breast cancer
family history ovarian cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014