The TUBA-WISP II study is an international prospective multicenter preference trial in which women choose their preferred risk-reducing strategy: either standard salpingo-oophorectomy (RRSO) or the experimental strategy of salpingectomy (RRS) with delayed oophorectomy (DO).
The study is cooperatively coordinated by the Radboudumc, Nijmegen, The Netherlands and the MD Anderson, Texas, USA.
The study is registered at ClinicalTrials: https://clinicaltrials.gov/ct2/show/NCT04294927
The primary objective is to prove that RRS with DO is non-inferior to the current standard RRSO regarding ovarian cancer risk.
Primary outcome measure: cumulative ovarian cancer incidence at target age: 46 for BRCA1 and 51 for BRCA2-PV carriers
Secondary outcome measures: incidence of (pre)malignancies in fallopian tubes and/or ovaries, incidence of non-ovarian pelvic cancer and breast cancer, peri-operative morbidity and mortality, uptake of prophylactic breast surgery and uptake of risk-reducing oophorectomy.
- Premenopausal women with a documented class IV or V pathogenic variant in the BRCA1, BRCA2, BRIP1, RAD51C, or RAD51D gene
- Age 25-40 years for BRCA1, 25-45 years for BRCA2 and 25-50 years for BRIP1, RAD51C, and RAD51D carriers
- Childbearing completed
- Presence of at least one fallopian tube
- Participants may have a personal history of a non-ovarian malignancy
- Informed consent must be obtained and documented according to national and local regulatory requirement
- Postmenopausal status (natural menopause or due to (cancer) treatment)
- Wish for second stage oophorectomy within two years after RRS (if clear at enrollment)
- Legally incapable
- Prior bilateral salpingectomy
- A personal history of ovarian, fallopian tube or peritoneal cancer
- Current clinical signs, diagnosis or treatment for malignant disease
The aimed sample size is 3000 women: 1500 BRCA1 and 1500 BRCA2 pathogenic variant carriers.
Women with a BRIP1, RAD51C, or RAD51D pathogenic variant can participate in the study, but will not contribute to the sample size or the primary outcome.
All data will be collected in a web-based electronic database including Case Report Forms (CRFs) and questionnaires.
At inclusion (prior to surgery)
- Baseline characteristics
- In- and exclusion criteria
- Questionnaire to be completed by patient
After surgery (within three months)
- Surgical outcomes
- Histopathological outcomes
- (non-) ovarian pelvic cancer
- breast cancer
- uptake of preventive breast surgery
- uptake of risk-reducing oophorectomy (in the arm choosing salpingectomy with delayed oophorectomy)
Three methods of annual follow-up are allowed: 1) annual out-patient visit and physician completes CRF, 2) patients completes a yearly questionnaire, 3) yearly assessment of a nationwide pathology database
Visualization of data collection.
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