TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
Status: Recruiting
Location: See all (66) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 50
Healthy Volunteers: f
View:
• Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
• Age at inclusion;
‣ BRCA1: 25-40 years
⁃ RAD51C, RAD51D, BRIP1: 25-50 years
• Childbearing completed
• Presence of at least one fallopian tube
• Participants may have a personal history of non-ovarian malignancy
• Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
Locations
United States
Illinois
UChicago Medicine
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University Medical Center
RECRUITING
St Louis
North Carolina
Duke University Hospital
RECRUITING
Durham
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Texas
Harris Health Lyndon B. Johnson Hospital
RECRUITING
Houston
MD Anderson Cancer Centre
RECRUITING
Houston
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Greenslopes Private Hospital
RECRUITING
Brisbane
Royal Brisbane Hospital
RECRUITING
Brisbane
St Andrew War Memorial Hospital
RECRUITING
Brisbane
The Mater Hospital
RECRUITING
Brisbane
Frances Perry House
RECRUITING
Melbourne
Mercy Hospital
RECRUITING
Melbourne
Monash Health
RECRUITING
Melbourne
Peter MacCallum Centre
RECRUITING
Melbourne
Royal Womens Hospital
RECRUITING
Melbourne
King Edward Memorial Hospital
RECRUITING
Perth
Epworth Hospital
RECRUITING
Richmon
Western Health
RECRUITING
St Albans
Chris O'Brien Lifehouse
RECRUITING
Sydney
Westmead hospital
RECRUITING
Sydney
Austria
Medical University of Graz
RECRUITING
Graz
Belgium
Hopital Universitaire Bruxelles
RECRUITING
Brussels
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Brazil
AC Camargo Cancer Centre
RECRUITING
São Paulo
Canada
Vancouver General Hospital
RECRUITING
Vancouver
Germany
Klinikum St. Marien Amberg
NOT_YET_RECRUITING
Amberg
Evangelische Waldkrankenhaus Spandau Berlin
RECRUITING
Berlin-spandau
Klinikum Lippe Detmold
NOT_YET_RECRUITING
Detmold
Evang. Kliniken Essen-Mitte
RECRUITING
Essen
Ireland
Cork University Hospital
RECRUITING
Cork
Italy
Universita di Bologna
RECRUITING
Bologna
Humanitas San Pio X
RECRUITING
Milan
San Gerardo Hospital
RECRUITING
Monza
Gemelli Hospital
RECRUITING
Rome
Mexico
Instituto Nacional de Cancerología
RECRUITING
Mexico City
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Amphia
RECRUITING
Breda
Catharina Ziekenhuis
RECRUITING
Eindhoven
Medisch Spectrum Twente
RECRUITING
Enschede
University Medical Center Groningen
RECRUITING
Groningen
Medical Center Leeuwarden
RECRUITING
Leeuwarden
Leiden University Medical Center
RECRUITING
Leiden
Maastricht University Medical Center
RECRUITING
Maastricht
Radboudumc
RECRUITING
Nijmegen
Erasmus Medical Center
RECRUITING
Rotterdam
Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
University Medical Center Utrecht
RECRUITING
Utrecht
Maxima Medical Center
RECRUITING
Veldhoven
Isala Klinieken
RECRUITING
Zwolle
Norway
Akershus University Hospital
ACTIVE_NOT_RECRUITING
Nordbyhagen
Oslo University Hospital
RECRUITING
Oslo
Stavanger Uniersity Hospital
RECRUITING
Stavanger
Poland
Gdynia Oncology Centre
RECRUITING
Gdynia
Bonifraterskie Centrum Medyczne
RECRUITING
Katowice
Medical University of Silesia
RECRUITING
Katowice
National Cancer Institute Warsaw
RECRUITING
Warsaw
Spain
Vall D'Hebron Barcelona
RECRUITING
Barcelona
Sweden
Karolinksa Institutet
RECRUITING
Stockholm
Uruguay
Hospital Británico
RECRUITING
Montevideo
Contact Information
Primary
Joanne A. de Hullu, MD, PhD
Joanne.deHullu@radboudumc.nl
+31 (0) 24 36 16683
Backup
Karen H. Lu, MD, PhD
khlu@mdanderson.org
(713) 745-8902
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2040-02-17
Participants
Target number of participants: 3000
Treatments
Experimental: Risk-reducing salpingectomy with delayed oophorectomy
Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
Active_comparator: Risk-reducing salpingo-oophorectomy
Risk-reducing salpingo-oophorectomy.
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Nijmegen