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TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.

NCT ID: NCT04294927Sponsor: University Medical Center NijmegenLast updated: 2026-04-06

Summary

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Detailed description

In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Arms & interventions

  • ProcedureRisk-reducing salpingectomy with delayed oophorectomy

    * BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45). * BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50). * BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)

  • ProcedureRisk-reducing salpingo-oophorectomy

    * BRCA1 at a maximum age of 40 (advised between age 35 and 40) * BRCA2 at a maximum age of 45 (advised between age 40 and 45) * BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)

Outcome measures

Primary

  • High grade serous (ovarian) cancer incidence

    High grade serous (ovarian) cancer incidence

    Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

Secondary

  • Incidence of (pre)malignant findings in tubes/ovaries

    Time frame: 6 weeks after each surgery

  • Peri-operative morbidity and mortality

    Time frame: 6 weeks after each surgery

  • Incidence of pelvic cancer (other than ovarian cancer)

    Time frame: Up to the age of 70

  • Incidence of breast cancer

    Time frame: Up to the age of 70

  • Uptake of risk reducing oophorectomy

    Time frame: Up to the age of 70

Eligibility criteria

Sex: FemaleAge: 25 Years to 50 YearsHealthy volunteers: No
Inclusion Criteria: * Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers. * Age at inclusion; * BRCA1: 25-40 years * BRCA2: 25-45 years * RAD51C, RAD51D, BRIP1: 25-50 years * Childbearing completed * Presence of at least one fallopian tube * Participants may have a personal history of non-ovarian malignancy * Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution. Exclusion Criteria: * Postmenopausal status (natural menopause or due to treatment) * Wish for second stage RRO within two years after RRS * Legally incapable * Prior bilateral salpingectomy * A personal history of ovarian, fallopian tube or peritoneal cancer * Current diagnosis or treatment for malignant disease

Study locations (11)

UChicago Medicine

Chicago, Illinois, 60637

Recruiting
Kathryn Mills · Contact

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Karen Lu · Contact

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Karen Lu · Contact

Washington University Medical Center

St Louis, Missouri, 63110

Recruiting
Andrea Hagemann · Contact

Mount Sinai Hospital

New York, New York, 10029

Recruiting
Stephanie Blank · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Kara Long Roche · Contact

Duke University Hospital

Durham, North Carolina, 27705

Recruiting
Haley Moss · Contact

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Sarah Kim · Contact

Harris Health Lyndon B. Johnson Hospital

Houston, Texas, 77026

Recruiting
Michaela Onstad-Grinsfelder · Contact

MD Anderson Cancer Centre

Houston, Texas, 77030-4009

Recruiting
Karen Lu · Contact

University of Washington

Seattle, Washington, 98195

Recruiting
Elizabeth Swisher · Contact

References

  • Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7.(PubMed)
  • Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: 10.1136/ijgc-2023-004377.(PubMed)