RecruitingNot ApplicableNCT04294927

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

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.


Sponsor

University Medical Center Nijmegen

Enrollment

3,000 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 25 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether removing the fallopian tubes first and delaying ovary removal can reduce ovarian cancer risk while preserving quality of life in women with inherited gene mutations that raise their cancer risk. **You may be eligible if...** - You carry a confirmed BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1 gene mutation - You are between 25 and 40 (BRCA1), 25 and 45 (BRCA2), or 25 and 50 (RAD51C/D, BRIP1) - You have completed childbearing - You have at least one fallopian tube in place **You may NOT be eligible if...** - You are postmenopausal - You want to have your ovaries removed within the next 2 years - You have already had both fallopian tubes removed - You have a personal history of ovarian, fallopian tube, or peritoneal cancer - You are currently being treated for another cancer - You are legally unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERisk-reducing salpingectomy with delayed oophorectomy

* 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)

PROCEDURERisk-reducing salpingo-oophorectomy

* 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)


Locations(66)

UChicago Medicine

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Medical Center

St Louis, Missouri, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Harris Health Lyndon B. Johnson Hospital

Houston, Texas, United States

MD Anderson Cancer Centre

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Chris O'Brien Lifehouse

Sydney, New South Wales, Australia

Westmead hospital

Sydney, New South Wales, Australia

St Andrew War Memorial Hospital

Brisbane, Queensland, Australia

Royal Brisbane Hospital

Brisbane, Queensland, Australia

Greenslopes Private Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Frances Perry House

Melbourne, Victoria, Australia

Mercy Hospital

Melbourne, Victoria, Australia

Epworth Hospital

Richmon, Victoria, Australia

Western Health

St Albans, Victoria, Australia

King Edward Memorial Hospital

Perth, Western Australia, Australia

The Mater Hospital

Brisbane, Australia

Monash Health

Melbourne, Australia

Peter MacCallum Centre

Melbourne, Australia

Royal Womens Hospital

Melbourne, Australia

Medical University of Graz

Graz, Austria

Hopital Universitaire Bruxelles

Brussels, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

AC Camargo Cancer Centre

São Paulo, Brazil

Vancouver General Hospital

Vancouver, Canada

Klinikum St. Marien Amberg

Amberg, Germany

Evangelische Waldkrankenhaus Spandau Berlin

Berlin-Spandau, Germany

Klinikum Lippe Detmold

Detmold, Germany

Evang. Kliniken Essen-Mitte

Essen, Germany

Cork University Hospital

Cork, Ireland

Universita di Bologna

Bologna, Italy

Humanitas San Pio X

Milan, Italy

San Gerardo Hospital

Monza, Italy

Gemelli Hospital

Rome, Italy

Instituto Nacional de Cancerología

Mexico City, Mexico

Radboudumc

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, North Brabant, Netherlands

Amsterdam University Medical Center

Amsterdam, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Amphia

Breda, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Medical Center Leeuwarden

Leeuwarden, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Maxima Medical Center

Veldhoven, Netherlands

Isala Klinieken

Zwolle, Netherlands

Akershus University Hospital

Nordbyhagen, Norway

Oslo University Hospital

Oslo, Norway

Stavanger Uniersity Hospital

Stavanger, Norway

Gdynia Oncology Centre

Gdynia, Poland

Bonifraterskie Centrum Medyczne

Katowice, Poland

Medical University of Silesia

Katowice, Poland

National Cancer Institute Warsaw

Warsaw, Poland

Vall D'Hebron Barcelona

Barcelona, Spain

Karolinksa Institutet

Stockholm, Sweden

Hospital Británico

Montevideo, Uruguay

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NCT04294927


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