Long-term morbidity and health after early menopause due to oophorectomy in women at increased risk of ovarian cancer: Protocol for a nationwide cross-sectional study with prospective follow-up (HARMOny Study)
| Autor: | Marijke R. Wevers, M. Carola Zillikens, C. H. Mom, Eveline M. A. Bleiker, Klaartje van Engelen, Tim Leiner, Helena C. van Doorn, Lizet E. van der Kolk, Matti A. Rookus, Christi J. van Asperen, Margreet G. E. M. Ausems, Jeanine E. Roeters van Lennep, Sanne B. Schagen, Eleonora B.L. van Dorst, Marc van Beurden, Michael Hauptmann, Joanne A. de Hullu, Neil K. Aaronson, Maartje J. Hooning, Brigitte F. M. Slangen, Bernadette A. M. Heemskerk-Gerritsen, Marian J.E. Mourits, Katja N. Gaarenstroom, Encarna B. Gomez-Garcia, Irma van de Beek, Flora E. van Leeuwen, Margriet Collée, Lieke P.V. Berger, Lara Terra, Angela H.E.M. Maas |
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| Přispěvatelé: | Human Genetics, ARD - Amsterdam Reproduction and Development, Psychology Other Research (FMG), Klinische Psychologie (Psychologie, FMG), Medical Oncology, Internal Medicine, Obstetrics & Gynecology, Clinical Genetics, Obstetrics and gynaecology, CCA - Cancer Treatment and quality of life, Amsterdam Reproduction & Development (AR&D), Human genetics, Cancer Center Amsterdam, Epidemiology and Data Science, Damage and Repair in Cancer Development and Cancer Treatment (DARE), Targeted Gynaecologic Oncology (TARGON), RS: GROW - R2 - Basic and Translational Cancer Biology, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Klinische Genetica, MUMC+: DA KG Polikliniek (9) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pediatrics
medicine.medical_specialty Cross-sectional study medicine.medical_treatment Health-related quality of life Computer applications to medicine. Medical informatics Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] R858-859.7 REDUCING SALPINGO-OOPHORECTOMY 030204 cardiovascular system & hematology ISCHEMIC-HEART-DISEASE 03 medical and health sciences 0302 clinical medicine Breast cancer Cognition SDG 3 - Good Health and Well-being Quality of life QUALITY-OF-LIFE CORONARY-ARTERY CALCIUM BRCA1/2 medicine Protocol BREAST-CANCER Medical history business.industry HORMONE REPLACEMENT THERAPY Oophorectomy Hormone replacement therapy (menopause) General Medicine medicine.disease Institutional review board Cardiovascular disease Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] Risk-reducing salpingo-oophorectomy CARDIOVASCULAR-DISEASE 030220 oncology & carcinogenesis BRCA1/2 MUTATION CARRIERS Cohort Medicine Osteoporosis BONE-MINERAL DENSITY business GLYCATION END-PRODUCTS Rare cancers Radboud Institute for Health Sciences [Radboudumc 9] |
| Zdroj: | JMIR research protocols, 10(1):e24414. JMIR Publications Inc. JMIR Research Protocols JMIR Research Protocols, 10(1). JMIR PUBLICATIONS, INC Terra, L, Hooning, M J, Heemskerk-Gerritsen, B A M, van Beurden, M, Roeters van Lennep, J E, van Doorn, H C, de Hullu, J A, Mom, C, van Dorst, E B L, Mourits, M J E, Slangen, B F M, Gaarenstroom, K N, Carola Zillikens, M, Leiner, T, van der Kolk, L, Collee, M, Wevers, M, Ausems, M G E M, van Engelen, K, Berger, L P V, van Asperen, C J, Gomez-Garcia, E B, van de Beek, I, Rookus, M A, Hauptmann, M, Bleiker, E M, Schagen, S B, Aaronson, N K, Maas, A H E M & van Leeuwen, F E 2021, ' Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer : Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study) ', JMIR Research Protocols, vol. 10, no. 1, e24414, pp. e24414 . https://doi.org/10.2196/24414, https://doi.org/10.2196/24414 JMIR Research Protocols, 10 JMIR Research Protocols, 10, 1 JMIR Research Protocols, 10(1):e24414. JMIR Publications Inc. JMIR Research Protocols, Vol 10, Iss 1, p e24414 (2021) JMIR research protocols, 10(1):24414. JMIR PUBLICATIONS, INC |
| ISSN: | 1929-0748 |
| DOI: | 10.2196/24414 |
| Popis: | Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793. International Registered Report Identifier (IRRID) DERR1-10.2196/24414 |
| Databáze: | OpenAIRE |
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