Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma (LUSTIC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02039388 |
Recruitment Status :
Recruiting
First Posted : January 17, 2014
Last Update Posted : April 1, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 : | December 2021 |
Estimated Study Completion Date : | March 2022 |

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 |
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Paul Speiser, Univ.Prof.Dr.med. | +436765367608 | paul.speiser@meduniwien.ac.at | |
Contact: Claudia Duwe | +436765536415 | c.duwe@ovartec.at |
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 |
Principal Investigator: | Paul Speiser, Univ.Prof.Dr.med. | Medical University Vienna, Dptm. of Obstetrics & Gynaecology |
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: | April 1, 2021 |
Last Verified: | March 2021 |
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 |
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 |