BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer
Conditions
Keywords
Salpingectomy, Delayed oophorectomy, Salpingo-oophorectomy, Quality of life, Ovarian cancer, BRCA
Brief summary
The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.
Detailed description
Eligible women will choose for the innovative or standard risk-reducing option themselves.
Interventions
PROCEDURESalpingectomy with delayed oophorectomy
Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.
PROCEDURERisk-reducing salpingo-oophorectomy
This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.
Sponsors
University Medical Center Nijmegen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation * Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 * Childbearing completed * Presence of at least one fallopian tube * Participants may have a personal history of non-ovarian malignancy
Exclusion criteria
* Postmenopausal status (natural menopause or due to (cancer) treatment) * Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment) * Legally incapable * Prior bilateral salpingectomy * A personal history of ovarian, fallopian tube or peritoneal cancer * Evidence of malignant disease at enrollment * Treatment for malignant disease at enrollment * Inability to read or speak Dutch BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause-related quality of life | Up to 5 years after last surgery | Measured by the Greene Climacteric Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life related items | Up to 15 years after last surgery | i.e. sexual functioning, cancer worry, satisfaction with decision |
| Surgery-related complications | 6 weeks after each surgery | Surgery-related complications |
| Histopathologic findings of removed fallopian tubes and ovaries | 6 weeks after each surgery | \- Histopathologic findings of removed fallopian tubes and ovaries |
| Cardiovascular risk factors | Up to 5 years after last surgery | Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases |
| General quality of life | Up to 15 years after last surgery | measured by several questionnaires |
| Incidence of ovarian cancer | Up to 15 years after last surgery | Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer) |
| Incidence of breast cancer | Up to 15 years after last surgery | Incidence of breast cancer |
| Cost-effectiveness of innovative preventive strategy | 10 years after last surgery | Costs per quality adjusted life year (QALY) |
| Incidence of cardiovascular diseases | Up to 15 years after last surgery | i.e. waist-hip circumference, Fasting blood sample |
Countries
Netherlands
Outcome results
None listed