TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
- Conditions
- BRIP1 Gene MutationBRCA1 Gene MutationRAD51D Gene MutationBRCA2 Gene MutationOvarian CancerRAD51C Gene Mutation
- Interventions
- Procedure: Risk-reducing salpingo-oophorectomyProcedure: Risk-reducing salpingectomy with delayed oophorectomy
- Registration Number
- NCT04294927
- Lead Sponsor
- University Medical Center Nijmegen
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 3000
-
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
- BRCA2: 25-45 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.
- Postmenopausal status (natural menopause or due to treatment)
- Wish for second stage RRO within two years after RRS
- Legally incapable
- Prior bilateral salpingectomy
- A personal history of ovarian, fallopian tube or peritoneal cancer
- Current diagnosis or treatment for malignant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risk-reducing salpingo-oophorectomy Risk-reducing salpingo-oophorectomy Risk-reducing salpingo-oophorectomy. Risk-reducing salpingectomy with delayed oophorectomy Risk-reducing salpingectomy with delayed oophorectomy Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
- Primary Outcome Measures
Name Time Method High grade serous (ovarian) cancer incidence Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers High grade serous (ovarian) cancer incidence
- Secondary Outcome Measures
Name Time Method Incidence of (pre)malignant findings in tubes/ovaries 6 weeks after each surgery Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
Incidence of pelvic cancer (other than ovarian cancer) Up to the age of 70 Incidence of pelvic cancer (other than ovarian cancer)
Peri-operative morbidity and mortality 6 weeks after each surgery Peri-operative morbidity and mortality
Incidence of breast cancer Up to the age of 70 Incidence of breast cancer
Uptake of risk reducing oophorectomy Up to the age of 70 Uptake of risk reducing oophorectomy after risk reducing salpingectomy
Trial Locations
- Locations (37)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
MD Anderson Cancer Centre
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Radboudumc
🇳🇱Nijmegen, Gelderland, Netherlands
Antoni van Leeuwenhoek
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Amsterdam University Medical Center
🇳🇱Amsterdam, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Instituto Nacional de Cancerología
🇲🇽Mexico City, Mexico
Elisabeth-TweeSteden Ziekenhuis
🇳🇱Tilburg, Brabant, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Maxima Medical Center
🇳🇱Veldhoven, Netherlands
Stavanger Uniersity Hospital
🇳🇴Stavanger, Norway
Gdynia Oncology Centre
🇵🇱Gdynia, Poland
Monash Health
🇦🇺Melbourne, Australia
Hopital Universitaire Bruxelles
🇧🇪Brussel, Belgium
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Akershus University Hospital
🇳🇴Nordbyhagen, Norway
Medical University of Silesia
🇵🇱Katowice, Poland
National Cancer Institute Warsaw
🇵🇱Warsaw, Poland
Hospital Británico
🇺🇾Montevideo, Uruguay
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Oslo University Hospital
🇳🇴Oslo, Norway
Bonifraterskie Centrum Medyczne
🇵🇱Katowice, Poland
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Peter MacCallum Centre
🇦🇺Melbourne, Australia
Universita di Bologna
🇮🇹Bologna, Italy
Royal Womens Hospital
🇦🇺Melbourne, Australia
AC Camargo Cancer Centre
🇧🇷São Paulo, Brazil
San Gerardo Hospital
🇮🇹Monza, Italy
Gemelli Hospital
🇮🇹Rome, Italy
Karolinksa Institutet
🇸🇪Stockholm, Sweden
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands