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

Ovarian Cancer Clinical Trial

— TUBA-WISP-II  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294927
• Other study ID #: NL 70691.091.19
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 17, 2040

Study information

• Verified date: April 2024
• Source: University Medical Center Nijmegen
• Contact: Joanne A. de Hullu, MD, PhD
• Phone: +31 (0) 24 36 16683
• Email: Joanne.deHullu[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 17, 2040
• Est. primary completion date: February 17, 2040
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Australia	Monash Health	Melbourne
Australia	Peter MacCallum Centre	Melbourne
Australia	Royal Womens Hospital	Melbourne
Belgium	Hopital Universitaire Bruxelles	Brussel
Belgium	Universitair Ziekenhuis Leuven	Leuven
Brazil	AC Camargo Cancer Centre	São Paulo
Italy	Universita di Bologna	Bologna
Italy	San Gerardo Hospital	Monza
Italy	Gemelli Hospital	Rome
Mexico	Instituto Nacional de Cancerología	Mexico City
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Elisabeth-TweeSteden Ziekenhuis	Tilburg	Brabant
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Maxima Medical Center	Veldhoven
Netherlands	Isala Klinieken	Zwolle
Norway	Akershus University Hospital	Nordbyhagen
Norway	Oslo University Hospital	Oslo
Norway	Stavanger Uniersity Hospital	Stavanger
Poland	Gdynia Oncology Centre	Gdynia
Poland	Bonifraterskie Centrum Medyczne	Katowice
Poland	Medical University of Silesia	Katowice
Poland	National Cancer Institute Warsaw	Warsaw
Sweden	Karolinksa Institutet	Stockholm
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	MD Anderson Cancer Centre	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington	Seattle	Washington
Uruguay	Hospital Británico	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Countries where clinical trial is conducted

United States,  Uruguay,  Australia,  Belgium,  Brazil,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High grade serous (ovarian) cancer incidence at the age of 70	Exploratory outcome measure	Up to the age of 70
Primary	High grade serous (ovarian) cancer incidence	High grade serous (ovarian) cancer incidence	Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Secondary	Incidence of (pre)malignant findings in tubes/ovaries	Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.	6 weeks after each surgery
Secondary	Peri-operative morbidity and mortality	Peri-operative morbidity and mortality	6 weeks after each surgery
Secondary	Incidence of pelvic cancer (other than ovarian cancer)	Incidence of pelvic cancer (other than ovarian cancer)	Up to the age of 70
Secondary	Incidence of breast cancer	Incidence of breast cancer	Up to the age of 70
Secondary	Uptake of risk reducing oophorectomy	Uptake of risk reducing oophorectomy after risk reducing salpingectomy	Up to the age of 70