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Assessing a new approach to reduce ovarian cancer risk in high-risk women

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.

Not applicable Interventional University Medical Center Nijmegen · NCT04294927

This study is testing a new surgery to see if removing just the fallopian tubes first can help women at high risk for ovarian cancer lower their chances of getting the disease while avoiding some of the side effects of more traditional surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3000 (estimated)
Ages25 Years to 50 Years
SexFemale
SponsorUniversity Medical Center Nijmegen Academic / other
Locations66 sites (Chicago, Illinois and 65 other locations)
Trial IDNCT04294927 on ClinicalTrials.gov

What this trial studies

This project evaluates the safety and effectiveness of risk-reducing salpingectomy with delayed oophorectomy as an alternative to the standard risk-reducing salpingo-oophorectomy in women with BRCA1/2 and other gene mutations. The study aims to determine the long-term effects of this innovative strategy on ovarian cancer incidence, given the high mortality rates associated with ovarian cancer and the limitations of current surveillance methods. Participants will undergo a surgical procedure to remove the fallopian tubes, with oophorectomy performed at a later date, allowing for a potential reduction in cancer risk while minimizing immediate menopause-related complications.

Who should consider this trial

Good fit: Ideal candidates include women aged 25-50 with a pathogenic BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1 mutation who have completed childbearing.

Not a fit: Patients who are postmenopausal or have a personal history of ovarian, fallopian tube, or peritoneal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the risk of ovarian cancer in high-risk women while reducing the immediate health impacts associated with traditional preventive surgeries.

How similar studies have performed: While the approach of risk-reducing salpingectomy with delayed oophorectomy is innovative, similar studies have suggested that most high-grade serous ovarian cancers originate in the fallopian tubes, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chicago, Illinois and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BRCA1 Gene MutationBRCA2 Gene MutationRAD51C Gene MutationRAD51D Gene MutationBRIP1 Gene MutationOvarian Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.