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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorUniversity Medical Center Nijmegen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Postmenopausal status (natural menopause or due to treatment)

Wish for second stage RRO within two years after RRS

Legally incapable

Prior bilateral salpingectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risk-reducing salpingectomy with delayed oophorectomy

    Procedure/Surgery

    * 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)

  • Risk-reducing salpingo-oophorectomy

    Procedure/Surgery

    * 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)

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Risk-reducing salpingectomy with delayed oophorectomyExperimental treatment 1 intervention
Group B: Risk-reducing salpingo-oophorectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

High grade serous (ovarian) cancer incidence

High grade serous (ovarian) cancer incidence

Time frame
Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

Secondary outcomes

1

Incidence of (pre)malignant findings in tubes/ovaries

Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.

Time frame
6 weeks after each surgery
2

Peri-operative morbidity and mortality

Peri-operative morbidity and mortality

Time frame
6 weeks after each surgery
3

Incidence of pelvic cancer (other than ovarian cancer)

Incidence of pelvic cancer (other than ovarian cancer)

Time frame
Up to the age of 70
4

Incidence of breast cancer

Incidence of breast cancer

Time frame
Up to the age of 70

Other outcomes

1

High grade serous (ovarian) cancer incidence at the age of 70

Exploratory outcome measure

Time frame
Up to the age of 70

Sponsors and contacts

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