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 (37) 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
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Texas
MD Anderson Cancer Centre
RECRUITING
Houston
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Australia
Monash Health
RECRUITING
Melbourne
Peter MacCallum Centre
RECRUITING
Melbourne
Royal Womens Hospital
RECRUITING
Melbourne
Belgium
Hopital Universitaire Bruxelles
RECRUITING
Brussels
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Brazil
AC Camargo Cancer Centre
RECRUITING
São Paulo
Italy
Universita di Bologna
RECRUITING
Bologna
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
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
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