Hereditary Breast and Ovarian Cancer, HBOC
Conditions
Interventions
Two clinical geneticists or two obstetricians/gynecologists (one from the Department of Obstetrics and Gynecology and the other from a department not directly involved in the study) will separately pr
Sponsors
Sapporo Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Mutation in the BRCA1 or BRCA2 gene of germ line cells 2. Have not yet developed ovarian cancer 3. ECOG PS of 0-1 4. Age between 20 and 80 years old The patient must have given written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with active multiple cancers (concurrent multiple cancers requiring therapeutic intervention) 2. Patients with a group of diseases that present severe systemic symptoms or active infectious diseases. 3. Any other cases that are deemed inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preventive effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in patients with pathological mutations in the germline BRCA1/2 genes and a confirmed diagnosis of hereditary breast and ovarian cancer syndrome (HBOC). Data will be collected on the time to occurrence. The time to occurrence is defined as the period from the date of registration to the date of occurrence or death of ovarian cancer, fallopian tube cancer, or peritoneal cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence or absence of ovarian cancer (occult cancer) detected at the time of RRSO Evaluation of the surgery (amount of blood loss, operative time, complications, etc.) Evaluation of postoperative QOL by RRSO (menopause score, QOL-ACD, etc.) Adverse events within 3 months after surgery Medical economic evaluation | — |
Countries
Japan
Contacts
Public ContactTasuku Mariya
Sapporo Medical University Obstetrics and Gynecology
Outcome results
None listed