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

  • STATUS
    Recruiting
  • End date
    Feb 17, 2040
  • participants needed
    3000
  • sponsor
    University Medical Center Nijmegen
Updated on 9 May 2021
cancer
oophorectomy
ovarian cancer
BRCA1
BRCA2
fallopian tube
rad51c
cancer of the ovary

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.

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Function, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRCA2 Mutation, Recurrent Ovarian Cancer, BRIP1 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Risk-reducing salpingo-oophorectomy, Risk-reducing salpingectomy with delayed oophorectomy
Clinical Study IdentifierNCT04294927
SponsorUniversity Medical Center Nijmegen
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note