Clinical trial NCT04294927: TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: BRCA1 Gene Mutation
BRCA2 Gene Mutation
RAD51C Gene Mutation
RAD51D Gene Mutation
BRIP1 Gene Mutation
Ovarian Cancer
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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: 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 outcomes:
measure: High grade serous (ovarian) cancer incidence
timeFrame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Secondary outcomes:
measure: Incidence of (pre)malignant findings in tubes/ovaries
timeFrame: 6 weeks after each surgery
measure: Peri-operative morbidity and mortality
timeFrame: 6 weeks after each surgery
measure: Incidence of pelvic cancer (other than ovarian cancer)
timeFrame: Up to the age of 70
measure: Incidence of breast cancer
timeFrame: Up to the age of 70
measure: Uptake of risk reducing oophorectomy
timeFrame: Up to the age of 70
Other outcomes:
measure: High grade serous (ovarian) cancer incidence at the age of 70
timeFrame: Up to the age of 70
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Houston
country: United States
facility: MD Anderson Cancer Centre
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Melbourne
country: Australia
facility: Monash Health
city: Melbourne
country: Australia
facility: Peter MacCallum Centre
city: Melbourne
country: Australia
facility: Royal Womens Hospital
city: Brussel
country: Belgium
facility: Hopital Universitaire Bruxelles
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: São Paulo
country: Brazil
facility: AC Camargo Cancer Centre
city: Bologna
country: Italy
facility: Universita di Bologna
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Rome
country: Italy
facility: Gemelli Hospital
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerología
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
state: Brabant
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Stavanger
country: Norway
facility: Stavanger Uniersity Hospital
city: Gdynia
country: Poland
facility: Gdynia Oncology Centre
city: Katowice
country: Poland
facility: Bonifraterskie Centrum Medyczne
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Warsaw
country: Poland
facility: National Cancer Institute Warsaw
city: Stockholm
country: Sweden
facility: Karolinksa Institutet
city: Montevideo
country: Uruguay
facility: Hospital Británico
Study officials:
affiliation: Radboud University Medical Center
name: Joanne A. de Hullu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Karen H. Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Rosella P.M.G. Hermens, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Elizabeth M. Swisher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: