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).
BRCA1/2
cardiovascular disease
cognition
health-related quality of life
osteoporosis
risk-reducing salpingo-oophorectomy
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
22 Jan 2021
22 Jan 2021
Historique:
received:
18
09
2020
accepted:
17
11
2020
revised:
13
11
2020
entrez:
22
1
2021
pubmed:
23
1
2021
medline:
23
1
2021
Statut:
epublish
Résumé
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. DERR1-10.2196/24414.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/24414.
Identifiants
pubmed: 33480862
pii: v10i1e24414
doi: 10.2196/24414
pmc: PMC7864779
doi:
Banques de données
ClinicalTrials.gov
['NCT03835793']
Types de publication
Journal Article
Langues
eng
Pagination
e24414Informations de copyright
©Lara Terra, Maartje J Hooning, Bernadette A M Heemskerk-Gerritsen, Marc van Beurden, Jeanine E Roeters van Lennep, Helena C van Doorn, Joanne A de Hullu, Constantijne Mom, Eleonora B L van Dorst, Marian J E Mourits, Brigitte F M Slangen, Katja N Gaarenstroom, M Carola Zillikens, Tim Leiner, Lizet van der Kolk, Margriet Collee, Marijke Wevers, Margreet G E M Ausems, Klaartje van Engelen, Lieke PV Berger, Christi J van Asperen, Encarna B Gomez-Garcia, Irma van de Beek, Matti A Rookus, Michael Hauptmann, Eveline M Bleiker, Sanne B Schagen, Neil K Aaronson, Angela H E M Maas, Flora E van Leeuwen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.01.2021.
Références
Fam Cancer. 2015 Dec;14(4):539-44
pubmed: 26264902
J Am Coll Cardiol. 2006 May 16;47(10):1976-83
pubmed: 16697313
N Engl J Med. 1999 Jun 10;340(23):1801-11
pubmed: 10362825
JAMA Cardiol. 2016 Oct 1;1(7):767-776
pubmed: 27627190
Menopause. 2012 Mar;19(3):272-7
pubmed: 21993082
Cancer Nurs. 2014 Jan-Feb;37(1):E44-50
pubmed: 23448956
Neurology. 2014 Jan 21;82(3):222-9
pubmed: 24336141
Lancet. 2011 Nov 12;378(9804):1707-16
pubmed: 22019144
J Clin Densitom. 2001 Winter;4(4):373-80
pubmed: 11748342
Atherosclerosis. 2016 Mar;246:367-73
pubmed: 26841074
Maturitas. 2018 May;111:69-76
pubmed: 29673834
Semin Oncol. 2006 Jun;33(3 Suppl 8):S2-7
pubmed: 16781283
Psychooncology. 2010 Mar;19(3):289-98
pubmed: 19382100
Breast Cancer Res Treat. 2016 Jan;155(2):285-93
pubmed: 26749359
Front Biosci (Elite Ed). 2012 Jan 01;4:976-97
pubmed: 22201929
J Clin Oncol. 2008 Mar 10;26(8):1331-7
pubmed: 18268356
PLoS Med. 2009 Nov;6(11):e1000181
pubmed: 19901981
Qual Life Res. 1996 Feb;5(1):81-90
pubmed: 8901370
Urology. 2017 Oct;108:59-64
pubmed: 28652167
J Clin Oncol. 2006 Aug 1;24(22):3576-82
pubmed: 16877724
J Hypertens. 2008 Mar;26(3):523-8
pubmed: 18300864
Br J Cancer. 2007 May 7;96(9):1335-42
pubmed: 17426707
J Clin Densitom. 2006 Jan-Mar;9(1):72-7
pubmed: 16731434
JAMA. 2017 Jun 20;317(23):2402-2416
pubmed: 28632866
Br J Clin Psychol. 1995 Nov;34(4):589-99
pubmed: 8563666
J Clin Epidemiol. 1998 Nov;51(11):1055-68
pubmed: 9817123
Obstet Gynecol. 2000 Sep;96(3):351-8
pubmed: 10960625
Neurourol Urodyn. 2015 Jan;34(1):24-31
pubmed: 24167010
Cancer Prev Res (Phila). 2012 Nov;5(11):1291-7
pubmed: 23009828
J Am Coll Cardiol. 2018 Dec 25;72(25):3374-3375
pubmed: 30573037
J Clin Oncol. 1994 Apr;12(4):843-50
pubmed: 8151327
Cochrane Database Syst Rev. 2018 Aug 24;8:CD012464
pubmed: 30141832
Fam Cancer. 2019 Jan;18(1):19-27
pubmed: 29881922
Curr Cardiovasc Imaging Rep. 2016;9:12
pubmed: 27057268
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Osteoporos Int. 2009 Aug;20(8):1347-52
pubmed: 19039511
BMC Med. 2017 Jan 4;15(1):2
pubmed: 28049531
Maturitas. 2003 Apr 25;44(4):279-86
pubmed: 12697368
Menopause. 2008 Jan-Feb;15(1):23-31
pubmed: 18257141
Eur J Cancer. 2015 Feb;51(3):400-8
pubmed: 25532426
Gynecol Oncol. 2005 May;97(2):476-82
pubmed: 15863147
Menopause. 2009 Jan-Feb;16(1):15-23
pubmed: 19034050
Eur J Cancer. 2017 Oct;84:159-167
pubmed: 28818705
BMJ. 2012 Sep 06;345:e5660
pubmed: 22956590
J Clin Exp Neuropsychol. 2018 Apr;40(3):253-273
pubmed: 28671504
JAMA. 2010 Sep 1;304(9):967-75
pubmed: 20810374
Diabetologia. 2004 Jul;47(7):1324-1330
pubmed: 15243705
J Natl Cancer Inst. 2009 Jan 21;101(2):80-7
pubmed: 19141781
Ann Biomed Eng. 2010 Mar;38(3):876-88
pubmed: 20127171
Maturitas. 2006 Jan 20;53(2):226-33
pubmed: 15955642
High Blood Press Cardiovasc Prev. 2018 Mar;25(1):65-77
pubmed: 29081017
Int J Gynecol Cancer. 2010 Feb;20(2):233-9
pubmed: 20169665
J Clin Oncol. 1996 Oct;14(10):2756-68
pubmed: 8874337
Maturitas. 2015 Mar;80(3):318-22
pubmed: 25600260
PLoS One. 2017 Sep 20;12(9):e0185175
pubmed: 28931094
J Med Genet. 2014 Feb;51(2):98-107
pubmed: 24285858
J Natl Cancer Inst. 2015 Mar 18;107(5):
pubmed: 25788320
Am J Epidemiol. 2002 Feb 15;155(4):339-45
pubmed: 11836198
Climacteric. 2017 Jun;20(3):212-221
pubmed: 28509627
Crit Rev Oncol Hematol. 2014 Aug;91(2):159-71
pubmed: 24529552
J Bone Miner Metab. 2004;22(4):372-5
pubmed: 15221497
J Hypertens. 2009 Nov;27(11):2186-91
pubmed: 19834344
Ann Clin Biochem. 2014 Mar;51(Pt 2):189-202
pubmed: 24399365
J Hypertens. 2010 Oct;28(10):2068-75
pubmed: 20651604
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
Circulation. 2006 Jan 3;113(1):30-7
pubmed: 16365194
J Am Coll Cardiol. 2015 Oct 13;66(15):1643-53
pubmed: 26449133
Breast Cancer Res Treat. 1999 May;55(2):189-99
pubmed: 10481946
J Am Soc Nephrol. 2005 Dec;16(12):3687-93
pubmed: 16280473
Menopause. 2006 Mar-Apr;13(2):265-79
pubmed: 16645540
Neurourol Urodyn. 2018 Aug;37(6):1925-1930
pubmed: 29603780
Gynecol Oncol. 2016 Oct;143(1):113-119
pubmed: 27430397
Curr Treat Options Cardiovasc Med. 2017 Sep 25;19(11):85
pubmed: 28948466
J Clin Epidemiol. 1999 Apr;52(4):303-7
pubmed: 10235170
Am J Obstet Gynecol. 2009 Feb;200(2):140.e1-9
pubmed: 19019330
Maturitas. 2011 Nov;70(3):261-5
pubmed: 21893388
Neurodegener Dis. 2008;5(3-4):257-60
pubmed: 18322406
J Musculoskelet Neuronal Interact. 2012 Dec;12(4):192-8
pubmed: 23196261
Cardiovasc Diabetol. 2015 Sep 05;14:118
pubmed: 26341632
J Clin Oncol. 2005 Oct 1;23(28):6890-8
pubmed: 16129845
Menopause. 2011 Mar;18(3):262-6
pubmed: 21127440
Int J Cardiol. 2015 Apr 15;185:263-8
pubmed: 25814214
Arch Biochem Biophys. 2010 Nov 1;503(1):118-28
pubmed: 20637179
Oncology (Williston Park). 2014 Sep;28(9):797-804
pubmed: 25224480
Neurology. 2007 Sep 11;69(11):1074-83
pubmed: 17761551
J Clin Oncol. 2006 Jul 20;24(21):3361-6
pubmed: 16801631