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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

RECRUITINGN/ASponsored by University Medical Center Nijmegen
Actively Recruiting
PhaseN/A
SponsorUniversity Medical Center Nijmegen
Started2020-03-01
Est. completion2040-02-17
Eligibility
Age25 Years – 50 Years
SexFEMALE
Healthy vol.Accepted
Locations11 sites
View on ClinicalTrials.gov →

NCT04294927

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

Age: 25 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions7

BRCA1 Gene MutationBRCA2 Gene MutationBRIP1 Gene MutationCancerOvarian CancerRAD51C Gene MutationRAD51D Gene Mutation

Locations11 sites

UChicago Medicine
Chicago, Illinois, 60637
Kathryn Mills
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karen Lu
Mayo Clinic
Rochester, Minnesota, 55905
Karen Lu
Washington University Medical Center
St Louis, Missouri, 63110
Andrea Hagemann
Mount Sinai Hospital
New York, New York, 10029
Stephanie Blank

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