Clinical study of risk reducing salpingo-oophorectomy (RRSO) in patients with pathological variants of the BRCA1/2 gene
Not Applicable
Recruiting
- Conditions
- Hereditary Breast and Ovarian Cancer, HBOC
- Registration Number
- JPRN-UMIN000042914
- Lead Sponsor
- Sapporo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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