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

ID#: NCT05287451

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 10, 2022

End Date: December 26, 2026

Contact Information:
Roni Wilke, MD
(713) 822-4502
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:

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.

2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2

3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable

4. Presence of at least one fallopian tube

5. Participants may have a personal history of non-ovarian malignancy

6. Informed consent must be obtained and documented.

Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Postmenopausal status (natural menopause or due to (cancer) treatment)

2. Wish for second stage RRO within two years after RRS (if clear at enrollment)

3. Legally incapable

4. Prior bilateral salpingectomy

5. A personal history of ovarian, fallopian tube, or peritoneal cancer

6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
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