Clinical trial NCT02321228: Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ovarian Cancer
Keywords: Salpingectomy
Delayed oophorectomy
Salpingo-oophorectomy
Quality of life
Ovarian cancer
BRCA
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 510
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Menopause-related quality of life
timeFrame: Up to 5 years after last surgery
Secondary outcomes:
measure: General quality of life
timeFrame: Up to 15 years after last surgery
measure: Quality of life related items
timeFrame: Up to 15 years after last surgery
measure: Surgery-related complications
timeFrame: 6 weeks after each surgery
measure: Histopathologic findings of removed fallopian tubes and ovaries
timeFrame: 6 weeks after each surgery
measure: Cardiovascular risk factors
timeFrame: Up to 5 years after last surgery
measure: Incidence of cardiovascular diseases
timeFrame: Up to 15 years after last surgery
measure: Incidence of ovarian cancer
timeFrame: Up to 15 years after last surgery
measure: Incidence of breast cancer
timeFrame: Up to 15 years after last surgery
measure: Cost-effectiveness of innovative preventive strategy
timeFrame: 10 years after last surgery
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leeuwarden
country: Netherlands
facility: Medical Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
Study officials:
affiliation: University Medical Center Nijmegen
name: Joanne A de Hullu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Institute for Quality of Healtcare, UMCNijmegen
name: Rosella PM Hermens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Nijmegen
name: Nicoline Hoogerbrugge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.