RecruitingNot ApplicableNCT05287451
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
Sponsor
M.D. Anderson Cancer Center
Enrollment
100 participants
Start Date
May 10, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
- Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2
- No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable
- Presence of at least one fallopian tube
- Participants may have a personal history of non-ovarian malignancy
- Informed consent must be obtained and documented.
Exclusion Criteria7
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
- Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Interventions
OTHERRIsk-Reducing Salpingectomy (RRS)
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHERRisk-Reducing Oophorectomy-RRO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHERRisk-Reducing Salpingo-Oophorectomy-RRSO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05287451
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