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

Overview

About this study

The purpose of this study is to 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 in BRCA1/2 gene germline mutation carriers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C 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
3. Childbearing completed or no longer requires fallopian tubes
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:

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/04/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Jamie Bakkum-Gamez, M.D.	Open for enrollment	Contact information: Maureen Lemens C.C.R.C. (507) 293-1487 Lemens.Maureen@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Open for enrollment

Contact information:

Maureen Lemens C.C.R.C.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available

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