Patients with mutations in BRCA1/2, BRIP, RAD51C and RAD51D genes
Conditions
Interventions
Sponsors
Kyoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Mutations have been identified in the BRCA1/2, BRIP, RAD51C and RAD51D genes, and the patient wishes to undergo RRSO. (2) The patient should not have fertility problems and should already have a child. If the case of married woman, the patient's spouse's consent has been obtained. In the case of unmarried women, it is necessary that they have sufficient understanding of this matter. (3) The patient should be able to understand the symptoms that may occur after RRSO surgery, especially the symptoms associated with artificial menopause. (4) Patients should have received genetic counseling and have an understanding of the mutations in the BRCA1/2, BRIP, RAD51C, and RAD51D genes. (5) The patient understands that, in principle, RRSO should be performed at his/her own expense except for complications of other diseases for which salpingo-oophorectomy is covered by insurance. However, patients with previous BRCA1/2 mutations who have an insurance indication for breast cancer will be treated with insurance. (6) The patient understands the contents of this study and has given written consent.
Exclusion criteria
Exclusion criteria: (1) Patients who do not have sufficient judgment, are unconscious, or require consideration of the name of the disease (2) Patients with serious life-threatening complications. (3) Patients who are judged by the principal investigator to be inappropriate for inclusion in the study. (4) Patients whose consent has not been obtained or who have requested to withdraw their consent. (5) Any other patient whom the principal investigator or sub-investigator deems inappropriate to conduct this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term prognosis (incidence of peritoneal cancer, postoperative survival, cause of death, etc.) | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Safety of the surgery (considerations associated with RRSO, etc.) b) Onset of adverse events after surgery (other morbidity and mortality such as cardiovascular disease, artificial menopause, osteoporosis, unexpected complications, etc.) c) Quality of life after surgery d) Pathological examination of the removed bilateral ovaries, fallopian tubes (and uterus) (preparation of whole area histological sections) | — |
Countries
Japan
Contacts
Public ContactMana Taki
Kyoto University School on Medicine Department of Gynecology and Obstetrics
Outcome results
None listed