Trial record 1 of 1 for:
lustic
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. Read our disclaimer for details. |
| 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:
Medical University of Vienna
Information provided by (Responsible Party):
Paul Speiser, Prof.MD,, Medical University of Vienna
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Show Detailed Description
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ovarian cancer
| 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 :
- 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.
Information from the National Library of Medicine
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 |
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
| 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
| 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
| 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 |
| 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:
|
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Carcinoma in Situ 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 |