RecruitingNot Applicable

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

United States100 participantsStarted 2022-05-10

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 criteria

✕. 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.

What they're measuring

To evaluate the 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.

Timeframe: through study completion, an average of 15 years

Trial details

NCT IDNCT05287451

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-26

Contact for this trial

Roni Wilke, MD

(713) 822-4502 rnitecki@mdanderson.org

View on ClinicalTrials.gov More Ovarian Cancer trials