NCT04294927 TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
| NCT ID | NCT04294927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Nijmegen |
| Condition | BRCA1 Gene Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2040-02-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,000 participants in total. It began in 2020-03-01 with a primary completion date of 2040-02-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Joanne A. de Hullu, MD, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT04294927 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 50 Years, studying BRCA1 Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04294927 currently recruiting?
Yes, NCT04294927 is actively recruiting participants. Contact the research team at Joanne.deHullu@radboudumc.nl for enrollment information.
Where is the NCT04294927 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Rochester, United States, St Louis, United States and 11 additional locations.
Who is sponsoring the NCT04294927 clinical trial?
NCT04294927 is sponsored by University Medical Center Nijmegen. The principal investigator is Joanne A. de Hullu, MD, PhD at Radboud University Medical Center. The trial plans to enroll 3,000 participants.