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

Ovarian Cancer Clinical Trial

— TUBA  

Official title:

Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02321228
• Other study ID #: NL50048.091.14
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2035

Study information

• Verified date: November 2023
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 510
• Est. completion date: January 2035
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Salpingectomy with delayed oophorectomy
Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.
• Risk-reducing salpingo-oophorectomy
This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital	Amsterdam	Noord-Holland
Netherlands	VU University Medical center	Amsterdam
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Medical Center	Leeuwarden
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Elisabeth-TweeSteden Hospital	Tilburg	Noord-Brabant
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Maxima Medical Center	Veldhoven

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause-related quality of life	Measured by the Greene Climacteric Scale	Up to 5 years after last surgery
Secondary	General quality of life	measured by several questionnaires	Up to 15 years after last surgery
Secondary	Quality of life related items	i.e. sexual functioning, cancer worry, satisfaction with decision	Up to 15 years after last surgery
Secondary	Surgery-related complications	Surgery-related complications	6 weeks after each surgery
Secondary	Histopathologic findings of removed fallopian tubes and ovaries	- Histopathologic findings of removed fallopian tubes and ovaries	6 weeks after each surgery
Secondary	Cardiovascular risk factors	Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases	Up to 5 years after last surgery
Secondary	Incidence of cardiovascular diseases	i.e. waist-hip circumference, Fasting blood sample	Up to 15 years after last surgery
Secondary	Incidence of ovarian cancer	Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)	Up to 15 years after last surgery
Secondary	Incidence of breast cancer	Incidence of breast cancer	Up to 15 years after last surgery
Secondary	Cost-effectiveness of innovative preventive strategy	Costs per quality adjusted life year (QALY)	10 years after last surgery