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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.
Eligible women will choose for the innovative or standard risk-reducing option themselves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salpingectomy with delayed oophorectomy | Experimental | 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). |
|
| Risk-reducing salpingo-oophorectomy | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause-related quality of life | Measured by the Greene Climacteric Scale | Up to 5 years after last surgery |
| Measure | Description | Time Frame |
|---|---|---|
| General quality of life | measured by several questionnaires | Up to 15 years after last surgery |
| Quality of life related items | i.e. sexual functioning, cancer worry, satisfaction with decision |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Joanne A de Hullu, MD, PhD | University Medical Center Nijmegen | Principal Investigator |
| Rosella PM Hermens, PhD | Scientific Institute for Quality of Healtcare, UMCNijmegen | Principal Investigator |
| Nicoline Hoogerbrugge, MD, PhD | University Medical Center Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands | ||
| Catharina Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41730824 | Derived | 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. | |
| 34997316 |
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|
| 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. |
|
|
| Up to 15 years after last surgery |
| Surgery-related complications | Surgery-related complications | 6 weeks after each surgery |
| Histopathologic findings of removed fallopian tubes and ovaries | - Histopathologic findings of removed fallopian tubes and ovaries | 6 weeks after each surgery |
| 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 |
| Incidence of cardiovascular diseases | i.e. waist-hip circumference, Fasting blood sample | Up to 15 years after last surgery |
| Incidence of ovarian cancer | Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer) | Up to 15 years after last surgery |
| Incidence of breast cancer | Incidence of breast cancer | Up to 15 years after last surgery |
| Cost-effectiveness of innovative preventive strategy | Costs per quality adjusted life year (QALY) | 10 years after last surgery |
| Eindhoven |
| North Brabant |
| 5623 EJ |
| Netherlands |
| Elisabeth-TweeSteden Hospital | Tilburg | North Brabant | 5042 AD | Netherlands |
| Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital | Amsterdam | North Holland | 1066 CX | Netherlands |
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3015 CE | Netherlands |
| Academic Medical Center | Amsterdam | Netherlands |
| VU University Medical center | Amsterdam | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| Medical Center | Leeuwarden | Netherlands |
| Radboudumc | Nijmegen | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Maxima Medical Center | Veldhoven | Netherlands |
| Derived |
| 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. |
| 34081085 | Derived | 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. |
| 26286255 | Derived | 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. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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