TUbectomy with delayed oophorectomy as alternative for risk-reducing salpingo-oophorectomy in BrcA-Women to assess the Safety of Prevention: the TUBA-WISP II study
Recruiting
- Conditions
- hereditary breast and ovarian cancerBRCA mutation1003860810033283
- Registration Number
- NL-OMON55319
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 680
Inclusion Criteria
• Women with a class 5 (definitely pathogenic) BRCA1 or BRCA2 germline mutation
in one of the participating centers.
• Age at inclusion;
o BRCA1: 25-40 years
o BRCA2: 25-45 years
• Childbearing completed
• Presence of at least one fallopian tube
Exclusion Criteria
• 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study outcome is high grade serous (ovarian) cancer incidence at the<br /><br>age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>• High grade serous (ovarian) cancer incidence at the age of 70<br /><br>• Incidence of (pre)malignant findings in tubes/ovaries<br /><br>• Peri-operative morbidity and mortality<br /><br>• Incidence of pelvic cancer (other than ovarian cancer)<br /><br>• Breast cancer<br /><br>• Uptake of risk reducing oophorectomy</p><br>