Clinical trial · Interventional
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers
NCT02321228CI-TRIAL-00083356TUBAactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Gene Mutation | — | UNRESOLVED | — |
| BRCA2 Gene Mutation | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Risk-reducing salpingo-oophorectomy | Procedure | — | UNRESOLVED |
| Salpingectomy with delayed oophorectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Salpingectomy with delayed oophorectomy
- 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).
- interventionNames
- Procedure: Salpingectomy with delayed oophorectomy
- type
- ACTIVE_COMPARATOR
- label
- Risk-reducing salpingo-oophorectomy
- 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).
- interventionNames
- Procedure: Risk-reducing salpingo-oophorectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDGootzen 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. PMID 41730824
- DERIVEDvan 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. PMID 34997316
- DERIVEDSteenbeek 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. PMID 34081085
- DERIVEDHarmsen 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.