Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers (TUBA)

University Medical Center Nijmegen

Status: Active, not recruiting

Conditions: BRCA2 Gene Mutation; Ovarian Cancer; BRCA1 Gene Mutation

Treatments: Procedure: Risk-reducing salpingo-oophorectomy; Procedure: Salpingectomy with delayed oophorectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02321228

NL50048.091.14

Details and patient eligibility

About

The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Full description

Eligible women will choose for the innovative or standard risk-reducing option themselves.

Enrollment: 510 estimated patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
• Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
• Childbearing completed
• Presence of at least one fallopian tube
• Participants may have a personal history of non-ovarian malignancy

Exclusion criteria

• Postmenopausal status (natural menopause or due to (cancer) treatment)
• Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
• Legally incapable
• Prior bilateral salpingectomy
• A personal history of ovarian, fallopian tube or peritoneal cancer
• Evidence of malignant disease at enrollment
• Treatment for malignant disease at enrollment
• Inability to read or speak Dutch

BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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510 participants in 2 patient groups

Salpingectomy with delayed oophorectomy

Experimental group

Description:

Female BRCA mutation carriers can opt for early salpingectomy upon completion of childbearing, followed by second stage oophorectomy delayed for five years beyond current guideline ages for risk-reducing salpingo-oophorectomy (i.e. age 40-45 for BRCA1 mutation carriers and 45-50 for BRCA mutation carriers).

Treatment:

Procedure: Salpingectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy

Active Comparator group

Description:

Female BRCA mutation carriers can opt for standard risk-reducing salpingo-oophorectomy at current guideline ages (age 35-40 for BRCA1 mutation carriers and age 40-45 for BRCA2 mutation carriers).

Treatment:

Procedure: Risk-reducing salpingo-oophorectomy