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

Launched by UNIVERSITY MEDICAL CENTER NIJMEGEN · Mar 1, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help reduce the risk of ovarian cancer in women who have certain genetic mutations that increase their risk, such as BRCA1 and BRCA2. The study is comparing a procedure called salpingectomy, where the fallopian tubes are removed, followed by a later removal of the ovaries, to the traditional method of removing both the ovaries and fallopian tubes at the same time. The goal is to see if this new approach can safely lower the chances of developing ovarian cancer while providing more options for women.

To be eligible for this trial, women need to be between the ages of 25 and 50 and must have tested positive for specific genetic mutations linked to a higher risk of ovarian cancer. They should also have completed childbearing and have at least one fallopian tube remaining. Participants will need to provide informed consent, meaning they understand the study and agree to take part. Throughout the trial, participants can expect close monitoring and support from the research team to ensure their safety and well-being.

Gender

FEMALE

Eligibility criteria

• 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