TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
3000 patients around the world
Available in Brazil, Mexico, United States, Uruguay
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.
University Medical Center Nijmegen
2Research sites
3000Patients around the world
This study is for people with
Ovarian cancer
Ovarian cancer prophylaxis
Requirements for the patient
To 50 Years
Female
Medical requirements
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.
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.
Sites
AC Camargo Cancer Center
Recruiting
São Paulo, 01509-001
Instituto Nacional de Cancerología - Ciudad de México