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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
Locations4 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

Locations4 sites

Massachusetts

1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karen Lu

Minnesota

1 site
Mayo Clinic
Rochester, Minnesota, 55905
Karen Lu

Texas

1 site
MD Anderson Cancer Centre
Houston, Texas, 77030-4009
Karen Lu

Washington

1 site
University of Washington
Seattle, Washington, 98195
Elizabeth Swisher

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