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Trial record 1 of 1 for:    lustic
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Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma (LUSTIC)

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ClinicalTrials.gov Identifier: NCT02039388
Recruitment Status : Recruiting
First Posted : January 17, 2014
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Carcinoma in Situ Ovarian Cancer Procedure: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma
Study Start Date : November 2013
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
High risk patients for breast and/or ovarian cancer Procedure: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle



Primary Outcome Measures :
  1. Detection of "Serous Tubal Intraepithelial Carcinomas (STICs)" in the lavage fluid from the uterine cavity and proximal fallopian tubes. [ Time Frame: preoperative ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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

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): NCT02039388


Contacts
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Contact: Paul Speiser, Univ.Prof.Dr.med. +436765367608 paul.speiser@meduniwien.ac.at
Contact: Claudia Duwe +436765536415 c.duwe@ovartec.at

Locations
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Austria
Medical University Graz - Universitätsklinik f. Frauenheilkunde u. Geburtshilfe Active, not recruiting
Graz, Austria, 8036
Kepler University Linz Not yet recruiting
Linz, Austria, 4040
Contact: Wolfgang Geiling       wolfgang.geiling@kepleruniklinikum.at   
Medical University Vienna, Dptm. of Obstetrics & Gynaecology Recruiting
Vienna, Austria, 1090
Contact: Paul Speiser, Prof., M.D.    +436765367608    paul.speiser@meduniwien.ac.at   
Contact: Valentina Paspalj, M.D.    +43 69917258148    valentina.paspalj@meduniwien.ac.at   
Principal Investigator: Paul Speiser, M.D.         
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   
Sub-Investigator: Adriaan Vanderstichele, M.D.         
Czechia
Gynecological Oncology Center Department of Obstetrics and Gynecology Charles University in Prague Recruiting
Prague, Prague 2, Czechia, 12800
Contact: David Cibula, Prof.         
Contact: Zikan Michael, MD., PhD    +420 224 967 451    Michal.Zikan@lf1.cuni.cz   
Masaryk Memorial Cancer Institute Brno Recruiting
Brno, Czechia, 60200
Contact: Gabriel Jelenek, MUDr.       gabrieljelenek@gmail.com   
Charles University Pilsen Recruiting
Pilsen, Czechia, 30605
Contact: Jiri Bouda, Dr.       Jiří Bouda <boudaj@medima.cz>   
Denmark
Copenhagen University Hospital Rigshospitalet Terminated
Copenhagen, Denmark, 2100
Germany
Charité Univ., Berlin-Campus Virchow Clinic Terminated
Berlin, Germany, 13353
Klinik Essen Mitte (KEM) Terminated
Essen, Germany, 92 45136
Clinical Center University of Munich Terminated
München, Germany, 80799
Ireland
Trinity Centre for Health Sciences St. James's Hospital Active, not recruiting
Dublin, Ireland, 8
Netherlands
Radboud University Medical Centre Terminated
Nijmegen, Netherlands, 6525 GA
United Kingdom
University College London Cancer Institute Recruiting
London, United Kingdom, WC1E 6HX
Contact: Martin Widschwendter, Prof.       m.widschwendter@ucl.ac.uk   
Contact: Adam Rosenthal, M.D.       adam.rosenthal@ucl.ac.uk   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Paul Speiser, Univ.Prof.Dr.med. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
Publications:
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Responsible Party: Paul Speiser, Prof.MD,, Univ.Prof.Dr.med., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02039388    
Other Study ID Numbers: EK 1766/2013
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by Paul Speiser, Prof.MD,, 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:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders