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

RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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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

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

Condition: Ovarian Cancer, BRCA1 Gene Mutation and more
PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy and other drugs
Melbourne, Not Specified, Australia and more
Sponsor: University Medical Center Nijmegen

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.	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)
ACTIVE_COMPARATOR: Risk-reducing salpingo-oophorectomy Risk-reducing salpingo-oophorectomy.	PROCEDURE: 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)

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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References

Clinical Trials Gov: TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention