Spots Global Cancer Trial Database for TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
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Trial Identification
Brief Title: TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
Official Title: 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.
Study ID: NCT04294927
Study Description
Brief 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.
Detailed Description: In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.
Keywords
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
MD Anderson Cancer Centre, Houston, Texas, United States
University of Washington, Seattle, Washington, United States
Monash Health, Melbourne, , Australia
Peter MacCallum Centre, Melbourne, , Australia
Royal Womens Hospital, Melbourne, , Australia
Hopital Universitaire Bruxelles, Brussel, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
AC Camargo Cancer Centre, São Paulo, , Brazil
Universita di Bologna, Bologna, , Italy
San Gerardo Hospital, Monza, , Italy
Gemelli Hospital, Rome, , Italy
Instituto Nacional de Cancerología, Mexico City, , Mexico
Elisabeth-TweeSteden Ziekenhuis, Tilburg, Brabant, Netherlands
Radboudumc, Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center, Maastricht, Limburg, Netherlands
Catharina Ziekenhuis, Eindhoven, Noord-Brabant, Netherlands
Amsterdam University Medical Center, Amsterdam, , Netherlands
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Medical Center Leeuwarden, Leeuwarden, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Maxima Medical Center, Veldhoven, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Akershus University Hospital, Nordbyhagen, , Norway
Oslo University Hospital, Oslo, , Norway
Stavanger Uniersity Hospital, Stavanger, , Norway
Gdynia Oncology Centre, Gdynia, , Poland
Bonifraterskie Centrum Medyczne, Katowice, , Poland
Medical University of Silesia, Katowice, , Poland
National Cancer Institute Warsaw, Warsaw, , Poland
Karolinksa Institutet, Stockholm, , Sweden
Hospital Británico, Montevideo, , Uruguay
Contact Details
Name: Joanne A. de Hullu, MD, PhD
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Karen H. Lu, MD, PhD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Rosella P.M.G. Hermens, MD,PhD
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Elizabeth M. Swisher, MD, PhD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
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