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NCT Number: NCT02321228

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

BRCA1 Gene Mutation Adnexal Diseases BRCA2 Gene Mutation Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salpingectomy with delayed oophorectomy

Procedure

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.

Other names: Tubectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy

Procedure

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.

Other names: Bilateral prophylactic salpingo-oophorectomy

Primary outcomes

  1. Menopause-related quality of life

    Time frame: Up to 5 years after last surgery

    Measured by the Greene Climacteric Scale

Secondary outcomes

  1. General quality of life

    Time frame: Up to 15 years after last surgery

    measured by several questionnaires

  2. Quality of life related items

    Time frame: Up to 15 years after last surgery

    i.e. sexual functioning, cancer worry, satisfaction with decision

  3. Surgery-related complications

    Time frame: 6 weeks after each surgery

    Surgery-related complications

  4. Histopathologic findings of removed fallopian tubes and ovaries

    Time frame: 6 weeks after each surgery

    • Histopathologic findings of removed fallopian tubes and ovaries

  5. Cardiovascular risk factors

    Time frame: Up to 5 years after last surgery

    Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases

  6. Incidence of cardiovascular diseases

    Time frame: Up to 15 years after last surgery

    i.e. waist-hip circumference, Fasting blood sample

  7. Incidence of ovarian cancer

    Time frame: Up to 15 years after last surgery

    Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)

  8. Incidence of breast cancer

    Time frame: Up to 15 years after last surgery

    Incidence of breast cancer

  9. Cost-effectiveness of innovative preventive strategy

    Time frame: 10 years after last surgery

    Costs per quality adjusted life year (QALY)

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Registry information

Official study 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

Acronym: TUBA

Important dates

Study start
2015
Primary completion
2030
Study completion
2035
First posted
Dec 22, 2014
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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