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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 : Unknown
Verified June 2016 by Paul Speiser, Prof.MD,, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : January 17, 2014
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Contacts and Locations
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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: Nina Pecha, Dr.,MD. +436767168264 nina.pecha@meduniwien.ac.at

Locations
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Austria
Medical University Graz - Universitätsklinik f. Frauenheilkunde u. Geburtshilfe Recruiting
Graz, Austria, 8036
Contact: Karl Tamussino, Prof.Dr. (MD)       karl.tamussino@medunigraz.at   
Contact: Gunda Pristauz-Telsnigg, Priv.Doz. (MD)       Gunda.Pristauz-Telsnigg@klinikum-graz.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: Nina M Pecha, M.D.    +436767168264    nina.pecha@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.         
Czech Republic
Gynecological Oncology Center Department of Obstetrics and Gynecology Charles University in Prague Recruiting
Prague, Prague 2, Czech Republic, 12800
Contact: David Cibula, Prof.         
Contact: Zikan Michael, MD., PhD    +420 224 967 451    Michal.Zikan@lf1.cuni.cz   
Denmark
Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mansoor Raza, Prof.       mansoor.raza.mirza@regionh.dk   
Contact: Mikkel Rosendahl, PhD    +45 35459676    mikkel.rosendahl.03@regionh.dk   
Germany
Klinik Essen Mitte (KEM) 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   
Ireland
Trinity Centre for Health Sciences St. James's Hospital Recruiting
Dublin, Ireland, 8
Contact: Noreen Gleeson, Dr. M.B, B.Ch.         
Contact: Sharon O'Toole, PhD       shotoole@tcd.ie   
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
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 M Pecha, Dr.,MD. Medical University Vienna, Dptm. of Obstetrics & Gynaecology
More Information
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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
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

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 Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders