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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 25 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2020-03-01
Primary completion: 2040-02-17
Study completion finish: 2040-02-17
Study type
PREVENTION
Phase
NA
Trial ID
NCT04294927
Intervention or treatment
PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy
PROCEDURE: Risk-reducing salpingo-oophorectomy
Conditions
- • Ovarian Cancer
- • BRCA1 Gene Mutation
- • BRCA2 Gene Mutation
- • RAD51C Gene Mutation
- • RAD51D Gene Mutation
- • BRIP1 Gene Mutation
Find a site
Closest Location:
Monash Health
Research sites nearby
Select from list below to view details:
Monash Health
Melbourne, Not Specified, Australia
Peter MacCallum Centre
Melbourne, Not Specified, Australia
Royal Womens Hospital
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Risk-reducing salpingectomy with delayed oophorectomy
| PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy
|
ACTIVE_COMPARATOR: Risk-reducing salpingo-oophorectomy
| PROCEDURE: Risk-reducing salpingo-oophorectomy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 |
Peri-operative morbidity and mortality | Peri-operative morbidity and mortality | 6 weeks after each surgery |
Incidence of pelvic cancer (other than ovarian cancer) | Incidence of pelvic cancer (other than ovarian cancer) | Up to the age of 70 |
Incidence of breast cancer | Incidence of breast cancer | Up to the age of 70 |
Uptake of risk reducing oophorectomy | Uptake of risk reducing oophorectomy after risk reducing salpingectomy | Up to the age of 70 |
Frequently Asked Questions
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