hereditary breast and ovarian cancer
Conditions
Interventions
Innovative treatment: RRS when childbearing is completed with a delayed RRO
(BRCA1 at age 40-45
BRCA2 at age 45-50)
Standard treatment: RRSO (BRCA1 at age 35-40
BRCA2 at age 40-45)
BRCA 1/2
gene germline mutation carriers who opt for early RRS but still want RRO at the
age of the current standard treatment (BRCA1 35- 40, BRCA2 40-45), can choose
for the innovative treatment a
Sponsors
Gynaecologie en Verloskunde
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria: - Postmenopausal status (natural menopause or due to (cancer) treatment) - Wish for second stage RRO within two years after RRS (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 - Current treatment for malignant disease - Inability to read or speak Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcome is the difference in menopause related quality of life, measured by the Greene Climacteric Scale (GCS) at baseline and different time points in follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes include changes in cardiovascular risk factors, incidence of breast and/or ovarian cancer and cardiovascular disease, the cost-effectiveness, surgery-related outcome and pathologic findings of the removed fallopian tubes. Total duration of follow-up will be 15 years. | — |
Countries
Netherlands
Outcome results
None listed