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Active, not recruitingNCT02321228TUBAUpdated Dec 5, 2024

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

An interventional study of Salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in BRCA1 Gene Mutation, BRCA2 Gene Mutation and Ovarian Cancer, sponsored by University Medical Center Nijmegen. Active, not recruiting at 13 sites in Netherlands. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by University Medical Center Nijmegen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
510
Allocation
Non-randomized
Ages
25 Years to 45 Years
Sex
Female
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Study 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.

Read the detailed description

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

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Conditions studied

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Ovarian Cancer

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Keywords

  • Salpingectomy
  • Delayed oophorectomy
  • Salpingo-oophorectomy
  • Quality of life
  • Ovarian cancer
  • BRCA
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In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 510 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

University Medical Center Nijmegen is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
510 participants (estimated)

Study arms

  • Experimental
    Salpingectomy with delayed oophorectomy

    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).

    Procedure: Salpingectomy with delayed oophorectomy

  • Active comparator
    Risk-reducing salpingo-oophorectomy

    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).

    Procedure: Risk-reducing salpingo-oophorectomy

Interventions

  • ProcedureSalpingectomy 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.

    Also known as: Tubectomy with delayed oophorectomy

  • ProcedureRisk-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.

    Also known as: Bilateral prophylactic salpingo-oophorectomy

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What researchers measure

Primary outcomes

  1. Menopause-related quality of life

    Measured by the Greene Climacteric Scale

    Time frame: Up to 5 years after last surgery

Secondary outcomes

  1. General quality of life

    measured by several questionnaires

    Time frame: Up to 15 years after last surgery

  2. Quality of life related items

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

    Time frame: Up to 15 years after last surgery

  3. Surgery-related complications

    Surgery-related complications

    Time frame: 6 weeks after each surgery

  4. Histopathologic findings of removed fallopian tubes and ovaries

    - Histopathologic findings of removed fallopian tubes and ovaries

    Time frame: 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

    Time frame: Up to 5 years after last surgery

  6. Incidence of cardiovascular diseases

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

    Time frame: Up to 15 years after last surgery

  7. Incidence of ovarian cancer

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

    Time frame: Up to 15 years after last surgery

  8. Incidence of breast cancer

    Incidence of breast cancer

    Time frame: Up to 15 years after last surgery

  9. Cost-effectiveness of innovative preventive strategy

    Costs per quality adjusted life year (QALY)

    Time frame: 10 years after last surgery

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Study locations

13 sites
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References and documents

Publications

  • 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2015 (actual). Primary completion is estimated for Jan 2030, 180 months after the start.

Of 282 non-industry interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 76. This study's planned 180 months is above that.

Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 23 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2014
First posted
Dec 22, 2014
StartActual
Jan 2015
Primary completionEst.
Jan 2030
CompletionEst.
Jan 2035
Last update
Dec 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02321228
Lead sponsor
University Medical Center Nijmegen
Responsible party
Joanne A. de Hullu, MD, PhD (MD, PhD, gynecologic oncologist, principal clinician, University Medical Center Nijmegen) — Principal investigator
First posted
Dec 22, 2014
Start date
Jan 2015
Primary completion
Jan 2030 (estimated)
Completion
Jan 2035 (estimated)
Last update
Dec 5, 2024

Study contacts

Joanne A de Hullu, MD, PhD
principal investigator · University Medical Center Nijmegen
Rosella PM Hermens, PhD
principal investigator · Scientific Institute for Quality of Healtcare, UMCNijmegen
Nicoline Hoogerbrugge, MD, PhD
principal investigator · University Medical Center Nijmegen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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