Cardiovascular Diseases Clinical Trial
— HARMOnyOfficial title:
Favourable and Unfavourable Health Effects of Risk-Reducing Salpingo-Oophorectomy in Women With a High Genetic Risk of Ovarian Cancer
Verified date | September 2020 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Risk-Reducing Salpingo-Oophorectomy (RRSO) at the age of 35 to 45 years is recommended for
women with a high genetic risk for ovarian cancer. While this procedure decreases the risk of
ovarian cancer by 80-96%, it also results in an immediate menopause. Current research on
potential adverse effects of premenopausal risk-reducing salpingo-oophorectomy, such as
increased risk of cardiovascular disease, compromised bone health, cognitive dysfunction and
reduced quality of life, is limited, mostly due to short follow up.
The investigators will conduct a multicenter cross-sectional study nested in a cohort of BRCA
mutation carriers from 8 Dutch centers for hereditary cancer. Eligible participants are women
who underwent RRSO before the age of 45. The participants will be frequency-matched on
current age with women above the age of 55 without RRSO or with RRSO after the age of 55.
Participants will complete an online questionnaire containing various questions about
lifestyle, medical history, risk factors for cardiovascular disease, bone health, cognition
and quality of life. Participants will be asked to visit one of the participating hospitals
for a blood test, a cardiovascular assessment and a DEXA scan for determining bone mineral
density. Afterwards participants will be requested to perform the online Amsterdam Cognition
Scale.
Status | Enrolling by invitation |
Enrollment | 750 |
Est. completion date | January 1, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - RRSO before age 45 - RRSO after age 55 - no RRSO Exclusion Criteria: - metastatic disease - Premature ovarian insufficiency - Physical or mental problems interfering with a outpatient visit - nonbioabsorbable cardiac stent - insufficient understanding of the Dutch language |
Country | Name | City | State |
---|---|---|---|
Netherlands | Netherlands Cancer Institute - Antoni van Leeuwenhoek | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Dutch Cancer Society, Erasmus Medical Center, Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | What is the effect of premenopausal RRSO on risk of (contralateral) breast cancer and breast cancer-specific survival as assessed in a prospective setting within a well established cohort. | we will study the effect of RRSO on BC, contralateral breast cancer and ovarian cancer risk and prognosis after BC/ovarian cancer | 4 years | |
Primary | What is the prevalence of atherosclerotic diseases in women with RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by coronary artery calcium scoring in agatston units | Due to the lack of estrogen we expect more atherosclerotic diseases. | 4 years | |
Primary | What is the prevalence of atherosclerotic diseases in women with RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by pulse wave velocity in meters/second | Due to the lack of estrogen we expect more atherosclerotic diseases. | 4 years | |
Primary | What is the prevalence of atherosclerotic diseases in women with RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by high-sensitive CRP in miligram/liter | Due to the lack of estrogen we expect more atherosclerotic diseases. | 4 years | |
Primary | What is the prevalence of atherosclerotic diseases in women with RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by high-sensitive cardial Troponine T in microgram/liter | Due to the lack of estrogen we expect more atherosclerotic diseases. | 4 years | |
Primary | What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by dual-energy X-ray absoptiometry in T- and Z-scores | Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts, The DXA-scan is corrected for age, with lower values representing a worse outcome | 4 years | |
Primary | What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genetic risk of ovarian cancer with a natural menopause as assessed by instant vertebral assessment | Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts | 4 years | |
Primary | What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by beta-CTX in picogram/mililiter | Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts | 4 years | |
Primary | What is the prevalence of osteoporosis in women with a premenopausal RRSO compared to women with a high genenetic risk of ovarian cancer with a natural menopause as assessed by P1NP in miligram/liter | Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts | 4 years | |
Primary | What is the prevalence of cognitive decline in women with RRSO compared to women with a natural menopause as assessed by the Amsterdam Cognition Scan | There are some studies suggesting that an early menopause has an influence on cognition | 4 years | |
Secondary | Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the SF-36 | How do women with a premenopausal RRSO experience their life. The SF-36 questionnaire ranges from 36 to 149, with higher values representing a worse outcome | 4 years | |
Secondary | Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the EORTC-QLQ BR23. | How do women with a premenopausal RRSO experience their life. We measure the body image using the EORTC QLQ BR23, with ranges from 2 to 8, with higher values representing a worse outcome | 4 years | |
Secondary | Quality of life after a premenopausal RRSO compared to women from families with a high genetic risk of ovarian cancer with a natural menopause as assessed by validated questionnaires such as the FACT-ES | How do women with a premenopausal RRSO experience their life. The FACT-ES questionnaire ranges from 0 to 76, with higher values representing a worse outcome | 4 years | |
Secondary | What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the SAQ | Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency. The SAQ questionnaire scale has questions with different weights as described in Thirlaway et al. 1996 |
4 years | |
Secondary | What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the UDI-6 | Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency. The UDI-6 questionnaire scale has a range from 0 to 18, with higher values representing a worse outcome |
4 years | |
Secondary | What is the prevalence of urogenital problems in women with a RRSO compared to women with a natural menopause as assessed by validated questionnaires such as the IIQ-7 | Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency. The IIQ-7 questionnaire scale has a range from 0 to 24, with higher values representing a worse outcome |
4 years | |
Secondary | What is the prevalence of cardiovascular risk factors in women with RRSO compared to women with a high genetic risk of ovarian cancer as assessed by a questionnaire. | Are some risk factors for cardiovascular disease more prevalent in women with a premenopausal RRSO | 4 years |
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