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NCT04294927NARecruiting

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

University Medical Center Nijmegen

Start Date

3/1/2020

Completion Date

2/17/2040

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.

Detailed Description

In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Eligibility Criteria

Age Range: 25 years to 50 years

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

Interventions

PROCEDURE

Risk-reducing salpingectomy with delayed oophorectomy

PROCEDURE

Risk-reducing salpingo-oophorectomy

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Conditions

BRCA1 Gene MutationBRCA2 Gene MutationRAD51C Gene MutationRAD51D Gene MutationBRIP1 Gene MutationOvarian Cancer

Locations

UChicago Medicine

Chicago, Illinois 60637

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University Medical Center

St Louis, Missouri 63110

United States

Mount Sinai Hospital

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke University Hospital

Durham, North Carolina 27705

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Harris Health Lyndon B. Johnson Hospital

Houston, Texas 77026

United States

MD Anderson Cancer Centre

Houston, Texas 77030-4009

United States

University of Washington

Seattle, Washington 98195

United States

Chris O'Brien Lifehouse

Sydney, New South Wales 2050

Australia

Westmead hospital

Sydney, New South Wales 2145

Australia

St Andrew War Memorial Hospital

Brisbane, Queensland 4001

Australia

Royal Brisbane Hospital

Brisbane, Queensland 4006

Australia

Greenslopes Private Hospital

Brisbane, Queensland 4120

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Frances Perry House

Melbourne, Victoria 3050

Australia

Mercy Hospital

Melbourne, Victoria 3084

Australia

Epworth Hospital

Richmon, Victoria 3121

Australia

Western Health

St Albans, Victoria 3021

Australia

King Edward Memorial Hospital

Perth, Western Australia 6008

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 5623 EJ

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