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

NCT04294927 · tracked via the Priya Life Science Ireland tracker

Sponsor

University Medical Center Nijmegen

Phase

Not applicable

Started

2020-03-01

Last updated

2026-04-06

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Risk-reducing salpingectomy with delayed oophorectomyRisk-reducing salpingo-oophorectomy

Risk-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)

Risk-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)

Study 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

FEMALE

Min age

25 Years

Max age

50 Years

Healthy volunteers

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

Primary outcome measure(s)

High grade serous (ovarian) cancer incidence — Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
High grade serous (ovarian) cancer incidence

Trial sites (66)

Facility	City	Region	Status
UChicago Medicine	Chicago	Illinois	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Washington University Medical Center	St Louis	Missouri	Recruiting
Mount Sinai Hospital	New York	New York	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Duke University Hospital	Durham	North Carolina	Recruiting
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Harris Health Lyndon B. Johnson Hospital	Houston	Texas	Recruiting
MD Anderson Cancer Centre	Houston	Texas	Recruiting
University of Washington	Seattle	Washington	Recruiting
Chris O'Brien Lifehouse	Sydney	New South Wales	Recruiting
Westmead hospital	Sydney	New South Wales	Recruiting
St Andrew War Memorial Hospital	Brisbane	Queensland	Recruiting
Royal Brisbane Hospital	Brisbane	Queensland	Recruiting
Greenslopes Private Hospital	Brisbane	Queensland	Recruiting
Royal Adelaide Hospital	Adelaide	South Australia	Recruiting
Frances Perry House	Melbourne	Victoria	Recruiting
Mercy Hospital	Melbourne	Victoria	Recruiting
Epworth Hospital	Richmon	Victoria	Recruiting
Western Health	St Albans	Victoria	Recruiting
King Edward Memorial Hospital	Perth	Western Australia	Recruiting
The Mater Hospital	Brisbane	Australia	Recruiting
Monash Health	Melbourne	Australia	Recruiting
Peter MacCallum Centre	Melbourne	Australia	Recruiting
Royal Womens Hospital	Melbourne	Australia	Recruiting
Medical University of Graz	Graz	Austria	Recruiting
Hopital Universitaire Bruxelles	Brussels	Belgium	Recruiting
Universitair Ziekenhuis Leuven	Leuven	Belgium	Recruiting
AC Camargo Cancer Centre	São Paulo	Brazil	Recruiting
Vancouver General Hospital	Vancouver	Canada	Recruiting
Klinikum St. Marien Amberg	Amberg	Germany	Not Yet Recruiting
Evangelische Waldkrankenhaus Spandau Berlin	Berlin-Spandau	Germany	Recruiting
Klinikum Lippe Detmold	Detmold	Germany	Not Yet Recruiting
Evang. Kliniken Essen-Mitte	Essen	Germany	Recruiting
Cork University Hospital	Cork	Ireland	Recruiting
Universita di Bologna	Bologna	Italy	Recruiting
Humanitas San Pio X	Milan	Italy	Recruiting
San Gerardo Hospital	Monza	Italy	Recruiting
Gemelli Hospital	Rome	Italy	Recruiting

+ 26 more sites — see the full list on the official registry below.

Other trials for the same condition

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) Recruiting

Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Recruiting

Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Active, not recruiting

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). Active, not recruiting

A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04294927 on ClinicalTrials.gov ↗ ← All trials in Ireland