Terra Lara, Hooning Maartje J, Heemskerk-Gerritsen Bernadette A M, van Beurden Marc, Roeters van Lennep Jeanine E, van Doorn Helena C, de Hullu Joanne A, Mom Constantijne, van Dorst Eleonora B L, Mourits Marian J E, Slangen Brigitte F M, Gaarenstroom Katja N, Zillikens M Carola, Leiner Tim, van der Kolk Lizet, Collee Margriet, Wevers Marijke, Ausems Margreet G E M, van Engelen Klaartje, Berger Lieke Pv, van Asperen Christi J, Gomez-Garcia Encarna B, van de Beek Irma, Rookus Matti A, Hauptmann Michael, Bleiker Eveline M, Schagen Sanne B, Aaronson Neil K, Maas Angela H E M, van Leeuwen Flora E
Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.
Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, Netherlands.
JMIR Res Protoc. 2021 Jan 22;10(1):e24414. doi: 10.2196/24414.
BRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35 to 45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about the potential adverse effects of premenopausal RRSO, such as increased risk of cardiovascular disease, osteoporosis, cognitive dysfunction, and reduced health-related quality of life (HRQoL), is limited.
The aim of this study is to assess the long-term health effects of premenopausal RRSO on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning, and HRQoL in women with high familial risk of breast or ovarian cancer.
We will conduct a multicenter cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at high familial risk of breast or ovarian cancer. A total of 500 women who have undergone RRSO before 45 years of age, with a follow-up period of at least 10 years, will be compared with 250 women (frequency matched on current age) who have not undergone RRSO or who have undergone RRSO at over 55 years of age. Participants will complete an online questionnaire on lifestyle, medical history, cardiovascular risk factors, osteoporosis, cognitive function, urological complaints, and HRQoL. A full cardiovascular assessment and assessment of bone mineral density will be performed. Blood samples will be obtained for marker analysis. Cognitive functioning will be assessed objectively with an online neuropsychological test battery.
This study was approved by the institutional review board in July 2018. In February 2019, we included our first participant. As of November 2020, we had enrolled 364 participants in our study.
Knowledge from this study will contribute to counseling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. The results can also be used to offer health recommendations after RRSO.
ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24414.
建议BRCA1/2基因的突变携带者在35至45岁时接受降低风险的输卵管卵巢切除术（RRSO）。RRSO可大幅降低卵巢癌风险，但代价是立即进入更年期。关于绝经前RRSO的潜在不良影响，如心血管疾病风险增加、骨质疏松、认知功能障碍以及健康相关生活质量（HRQoL）下降等方面的知识有限。
本研究旨在评估绝经前RRSO对乳腺癌或卵巢癌家族风险高的女性在心血管疾病、骨骼健康、认知功能、泌尿系统症状、性功能以及HRQoL方面的长期健康影响。
我们将进行一项多中心横断面研究，并进行前瞻性随访，该研究嵌套于一个全国性的乳腺癌或卵巢癌家族风险高的女性队列中。将45岁之前接受RRSO且随访期至少10年的500名女性与250名未接受RRSO或55岁之后接受RRSO的女性（根据当前年龄进行频率匹配）进行比较。参与者将完成一份关于生活方式、病史、心血管危险因素、骨质疏松、认知功能、泌尿系统症状和HRQoL的在线问卷。将进行全面的心血管评估和骨密度评估。采集血样进行标志物分析。将使用在线神经心理测试组合客观评估认知功能。
本研究于2018年7月获得机构审查委员会批准。2019年2月，我们纳入了第一名参与者。截至2020年11月，我们的研究已招募了364名参与者。
本研究所得知识将有助于为乳腺癌/卵巢癌家族风险高的女性提供关于绝经前RRSO长期健康影响的咨询。研究结果还可用于在RRSO后提供健康建议。
ClinicalTrials.gov NCT03835793；https://clinicaltrials.gov/ct2/show/NCT03835793。
国际注册报告识别码（IRRID）：DERR1-10.2196/24414。
