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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University Medical Center Nijmegen
Study ID
NCT04294927
Status
Recruiting
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Conditions

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • BRIP1 Gene Mutation
  • Ovarian Cancer
  • RAD51C Gene Mutation
  • RAD51D Gene Mutation

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Risk-reducing salpingectomy with delayed oophorectomy — PROCEDURE
    * 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)
  • Risk-reducing salpingo-oophorectomy — PROCEDURE
    * 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)

Study Details

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.

Key Dates

Start date
Mar 1, 2020
Status verified
Oct 2025
Primary completion
Feb 17, 2040
Completion
Feb 17, 2040

Study Design

Enrollment
3,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Risk-reducing salpingectomy with delayed oophorectomy
    Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.
  • Active Comparator: Risk-reducing salpingo-oophorectomy
    Risk-reducing salpingo-oophorectomy.

Primary Outcome Measure

High grade serous (ovarian) cancer incidence [ Time Frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
UChicago MedicineChicagoIllinois60637
Kathryn Mills
Dana Farber Cancer InstituteBostonMassachusetts02215
Karen Lu
Mayo ClinicRochesterMinnesota55905
Karen Lu
Washington University Medical CenterSt LouisMissouri63110
Andrea Hagemann
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Kara Long Roche
Mount Sinai HospitalNew YorkNew York10029
Stephanie Blank
Duke University HospitalDurhamNorth Carolina27705
Haley Moss
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Sarah Kim
Harris Health Lyndon B. Johnson HospitalHoustonTexas77026
Michaela Onstad-Grinsfelder
MD Anderson Cancer CentreHoustonTexas77030-4009
Karen Lu
University of WashingtonSeattleWashington98195
Elizabeth Swisher

Find similar trials in Chicago, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UChicago Medicine· Chicago, ILDana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNWashington University Medical Center· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYMount Sinai Hospital· New York, NY

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