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BRCA1 Gene MutationTUBANCT02321228

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

A study testing Salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University Medical Center Nijmegen at 13 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 45 years, women only
What is being tested?
Salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
13 sitesNetherlands
Study dates
Jan 2015to Jan 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

13 sites in 1 country.

13 sites in 1 country

Netherlands13 sites

  • Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital

    Amsterdam, North Holland, 1066 CX

  • Academic Medical Center

    Amsterdam

  • VU University Medical center

    Amsterdam

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Medical Center

    Leeuwarden

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX

  • Radboudumc

    Nijmegen

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 CE

  • Elisabeth-TweeSteden Hospital

    Tilburg, North Brabant, 5042 AD

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Maxima Medical Center

    Veldhoven

Other trials in Netherlands

About this study

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

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.

Read the detailed description

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

Being tested
Salpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy
Keywords
Salpingectomy, Delayed oophorectomy, Salpingo-oophorectomy, Quality of life, Ovarian cancer, BRCA
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salpingectomy with delayed oophorectomyProcedure or surgery

    Also called Tubectomy 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-oophorectomyProcedure or surgery

    Also called Bilateral prophylactic 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.

Study groups in NCT02321228
Study groupRoleWhat they receive
Salpingectomy with delayed oophorectomyExperimentalFemale 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).
Receives: Procedure: Salpingectomy with delayed oophorectomy
Risk-reducing salpingo-oophorectomyActive comparatorFemale 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).
Receives: Procedure: Risk-reducing salpingo-oophorectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Menopause-related quality of life

    Measured by the Greene Climacteric Scale

    Measured: Up to 5 years after last surgery

Secondary outcomes (9)

  1. General quality of life

    measured by several questionnaires

    Measured: Up to 15 years after last surgery

  2. Quality of life related items

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

    Measured: Up to 15 years after last surgery

  3. Surgery-related complications

    Surgery-related complications

    Measured: 6 weeks after each surgery

  4. Histopathologic findings of removed fallopian tubes and ovaries

    • Histopathologic findings of removed fallopian tubes and ovaries

    Measured: 6 weeks after each surgery

  5. Cardiovascular risk factors

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

    Measured: Up to 5 years after last surgery

  6. Incidence of cardiovascular diseases

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

    Measured: Up to 15 years after last surgery

  7. Incidence of ovarian cancer

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

    Measured: Up to 15 years after last surgery

  8. Incidence of breast cancer

    Incidence of breast cancer

    Measured: Up to 15 years after last surgery

  9. Cost-effectiveness of innovative preventive strategy

    Costs per quality adjusted life year (QALY)

    Measured: 10 years after last surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02321228
Sponsor's protocol ID
NL50048.091.14
Acronym
TUBA
Status last verified
Dec 2024
First submitted
11 Dec 2014
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Gootzen TA, van Gelder MMHJ, Hermens RPMG, van Bommel MHD, Apperloo MJA, Arts-de Jong M, Zanten MMAB, Coppus SFPJ, Custers J, van Doorn HC, Gaarenstroom KN, Harmsen MG, Knippenberg M, van Lonkhuijzen LRCW, Piek JMJ, Simons M, Slangen BFM, Tros R, Vos MC, Yigit R, Zweemer RP, Hoogerbrugge N, Kets CM, Maas AHEM, Steenbeek MP, de Hullu JA. Development of cardiovascular risk factors in women with a BRCA1/2 pathogenic variant within five years after tubo-ovarian cancer risk reduction in the TUBA study. Maturitas. 2026 Apr;207:108886. doi: 10.1016/j.maturitas.2026.108886. Epub 2026 Feb 22.

    PubMed 41730824

  • van Bommel MHD, Steenbeek MP, IntHout J, Hermens RPMG, Hoogerbrugge N, Harmsen MG, van Doorn HC, Mourits MJE, van Beurden M, Zweemer RP, Gaarenstroom KN, Slangen BFM, Brood-van Zanten MMA, Vos MC, Piek JM, van Lonkhuijzen LRCW, Apperloo MJA, Coppus SFPJ, Prins JB, Custers JAE, de Hullu JA. Cancer worry among BRCA1/2 pathogenic variant carriers choosing surgery to prevent tubal/ovarian cancer: course over time and associated factors. Support Care Cancer. 2022 Apr;30(4):3409-3418. doi: 10.1007/s00520-021-06726-4. Epub 2022 Jan 8.

    PubMed 34997316

  • Steenbeek MP, Harmsen MG, Hoogerbrugge N, de Jong MA, Maas AHEM, Prins JB, Bulten J, Teerenstra S, van Bommel MHD, van Doorn HC, Mourits MJE, van Beurden M, Zweemer RP, Gaarenstroom KN, Slangen BFM, Brood-van Zanten MMA, Vos MC, Piek JMJ, van Lonkhuijzen LRCW, Apperloo MJA, Coppus SFPJ, Massuger LFAG, IntHout J, Hermens RPMG, de Hullu JA. Association of Salpingectomy With Delayed Oophorectomy Versus Salpingo-oophorectomy With Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Aug 1;7(8):1203-1212. doi: 10.1001/jamaoncol.2021.1590.

    PubMed 34081085

  • Harmsen MG, Arts-de Jong M, Hoogerbrugge N, Maas AH, Prins JB, Bulten J, Teerenstra S, Adang EM, Piek JM, van Doorn HC, van Beurden M, Mourits MJ, Zweemer RP, Gaarenstroom KN, Slangen BF, Vos MC, van Lonkhuijzen LR, Massuger LF, Hermens RP, de Hullu JA. Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study. BMC Cancer. 2015 Aug 19;15:593. doi: 10.1186/s12885-015-1597-y.

    PubMed 26286255

Questions about this trial

What is this clinical trial studying?

A study testing Salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University Medical Center Nijmegen at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopause-related quality of life (time frame: Up to 5 years after last surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02321228, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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