Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

NARECRUITING

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

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: FEMALE

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

PREVENTION

Phase

Study ID

NCT04294927

Intervention or treatment

PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy

PROCEDURE: Risk-reducing salpingo-oophorectomy

Conditions

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

Condition: BRCA1 Gene Mutation, BRCA2 Gene Mutation and more
PROCEDURE: Risk-reducing salpingectomy with delayed oophorectomy and other drugs
Melbourne, Australia and more
Sponsor: University Medical Center Nijmegen

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Monash Health

Select from list below to view details:

Monash Health
Melbourne, Australia
Peter MacCallum Centre
Melbourne, Australia
Royal Womens Hospital
Melbourne, Australia

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Who is running the clinical trial?

UMCN

University Medical Center Nijmegen

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
ACTIVE_COMPARATOR: Risk-reducing salpingo-oophorectomy Risk-reducing salpingo-oophorectomy.	Procedure: Risk-reducing salpingo-oophorectomy

What is the study measuring?

Primary Outcome

Measure	Description	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

Measure	Description	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

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

Claim this trial

References

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

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