<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835793</url>
  </required_header>
  <id_info>
    <org_study_id>M18HAR</org_study_id>
    <nct_id>NCT03835793</nct_id>
  </id_info>
  <brief_title>Health After eaRly Menopause Due to Oophorectomy</brief_title>
  <acronym>HARMOny</acronym>
  <official_title>Favourable and Unfavourable Health Effects of Risk-Reducing Salpingo-Oophorectomy in Women With a High Genetic Risk of Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Netherlands Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Risk-Reducing Salpingo-Oophorectomy (RRSO) at the age of 35 to 45 years is recommended for&#xD;
      women with a high genetic risk for ovarian cancer. While this procedure decreases the risk of&#xD;
      ovarian cancer by 80-96%, it also results in an immediate menopause. Current research on&#xD;
      potential adverse effects of premenopausal risk-reducing salpingo-oophorectomy, such as&#xD;
      increased risk of cardiovascular disease, compromised bone health, cognitive dysfunction and&#xD;
      reduced quality of life, is limited, mostly due to short follow up.&#xD;
&#xD;
      The investigators will conduct a multicenter cross-sectional study nested in a cohort of BRCA&#xD;
      mutation carriers from 8 Dutch centers for hereditary cancer. Eligible participants are women&#xD;
      who underwent RRSO before the age of 45. The participants will be frequency-matched on&#xD;
      current age with women above the age of 55 without RRSO or with RRSO after the age of 55.&#xD;
      Participants will complete an online questionnaire containing various questions about&#xD;
      lifestyle, medical history, risk factors for cardiovascular disease, bone health, cognition&#xD;
      and quality of life. Participants will be asked to visit one of the participating hospitals&#xD;
      for a blood test, a cardiovascular assessment and a DEXA scan for determining bone mineral&#xD;
      density. Afterwards participants will be requested to perform the online Amsterdam Cognition&#xD;
      Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing&#xD;
      salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/&#xD;
      year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC)&#xD;
      risk as well, due to reduced gonadal hormone levels. Besides favorable effects of RRSO on&#xD;
      ovarian cancer and, potentially, BC risk, RRSO induces immediate menopause, which may have&#xD;
      unfavorable long-term health consequences. Early menopause has been associated with increased&#xD;
      risks of cardiovascular disease (CVD), lower bone mineral density (BMD), cognitive&#xD;
      impairment, and decreased quality of life. Current evidence regarding these health effects is&#xD;
      mainly based on women with a natural early menopause, and it is unknown whether these results&#xD;
      hold for women undergoing RRSO at early premenopausal ages.&#xD;
&#xD;
      Objective: The investigators will investigate long-term health effects of premenopausal RRSO&#xD;
      on (subclinical) cardiovascular status, BMD, cognition and quality of life.&#xD;
&#xD;
      Study design: the investigators will assess long-term health effects of RRSO in a&#xD;
      cross-sectional study, among 500 women who underwent premenopausal RRSO compared to 250 women&#xD;
      of the same age without RRSO (or with RRSO after age 55). Eligible women will be invited to&#xD;
      participate in a screening program assessing cardiovascular status, bone mineral density,&#xD;
      cognitive functioning and quality of life.&#xD;
&#xD;
      Study population: Women are eligible for the premenopausal RRSO group if:&#xD;
&#xD;
        -  RRSO before the age of 45 years;&#xD;
&#xD;
        -  RRSO was done 10 or more years ago; Women are eligible for the comparison group without&#xD;
           premenopausal RRSO if the participant did not undergo RRSO before the age of 55 years,&#xD;
           and did not have a natural or therapy induced menopause before age 50.&#xD;
&#xD;
      Primary study outcome: To study long-term effects of premenopausal RRSO on:&#xD;
&#xD;
        -  (subclinical) CVD&#xD;
&#xD;
        -  BMD&#xD;
&#xD;
        -  Cognition&#xD;
&#xD;
      Secondary study outcome: To study long-term effects of premenopausal RRSO on:&#xD;
&#xD;
        -  Quality of life&#xD;
&#xD;
        -  Urogenital problems&#xD;
&#xD;
        -  Cardiovascular risk factors&#xD;
&#xD;
      Furthermore, the investigators will examine the influence of age at RRSO, time since RRSO,&#xD;
      hormone replacement therapy (HRT), carrier ship of a BRCA1 or BRCA2 mutation and BC history&#xD;
      on the outcome.&#xD;
&#xD;
      The obtained knowledge will assist physicians in counselling women with high ovarian cancer&#xD;
      risk and help them to make well-informed decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Due to the lack of estrogen we expect more atherosclerotic diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Due to the lack of estrogen we expect more atherosclerotic diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Due to the lack of estrogen we expect more atherosclerotic diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Due to the lack of estrogen we expect more atherosclerotic diseases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>There are some studies suggesting that an early menopause has an influence on cognition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>4 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.&#xD;
The SAQ questionnaire scale has questions with different weights as described in Thirlaway et al. 1996</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.&#xD;
The UDI-6 questionnaire scale has a range from 0 to 18, with higher values representing a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>4 years</time_frame>
    <description>Have women with a premenopausal RRSO more urogenital complaints due to longer duration of estrogen deficiency.&#xD;
The IIQ-7 questionnaire scale has a range from 0 to 24, with higher values representing a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>4 years</time_frame>
    <description>Are some risk factors for cardiovascular disease more prevalent in women with a premenopausal RRSO</description>
  </secondary_outcome>
  <other_outcome>
    <measure>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.</measure>
    <time_frame>4 years</time_frame>
    <description>we will study the effect of RRSO on BC, contralateral breast cancer and ovarian cancer risk and prognosis after BC/ovarian cancer</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Surgical Menopause</condition>
  <condition>BRCA1 Mutation</condition>
  <condition>BRCA2 Mutation</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Bone Mineral Density</condition>
  <condition>Cognitive Decline</condition>
  <condition>Quality of Life</condition>
  <condition>Menopause Surgical</condition>
  <arm_group>
    <arm_group_label>Early-RRSO</arm_group_label>
    <description>RRSO before the age of 45 years&#xD;
RRSO was done 10 or more years ago</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late-/non-RRSO group</arm_group_label>
    <description>Natural menopause ≥ 50 years of age&#xD;
No RRSO ≤ age of 55&#xD;
No treatment-induced menopause ≤ 50 years of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CAC-score</intervention_name>
    <description>Testing for possible unfavourable health effects of early surgical menopause</description>
    <arm_group_label>Early-RRSO</arm_group_label>
    <arm_group_label>Late-/non-RRSO group</arm_group_label>
    <other_name>Blood sampling</other_name>
    <other_name>DXA-scan</other_name>
    <other_name>Vertebral Fracture Assessment</other_name>
    <other_name>Online cognition test (Amsterdam Cognition Scale)</other_name>
    <other_name>Quality of life questionnaire</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Optional for studyparticipants is to collect and store DNA in a blood Biobank.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women are eligible if they underwent RRSO before age 45 and the RRSO was done 10 or more&#xD;
        years ago (early RRSO group) and women are eligible as control group if they did not&#xD;
        undergo RRSO, or underwent RRSO after age 55 while reaching natural menopause after the age&#xD;
        of 50 years. The comparison group will be frequency-matched with the RRSO group on&#xD;
        categories of calendar year of birth, and breast cancer history. For each patient with&#xD;
        breast cancer, the investigators will perform individual matching accounting for age at&#xD;
        breast cancer diagnosis and carrier status. For the early RRSO group the investigators&#xD;
        select women who underwent RRSO at least 10 years ago and are currently older than 55 years&#xD;
        because the investigators expect subclinical atherosclerosis not to manifest earlier.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RRSO before age 45&#xD;
&#xD;
          -  RRSO after age 55&#xD;
&#xD;
          -  no RRSO&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metastatic disease&#xD;
&#xD;
          -  Premature ovarian insufficiency&#xD;
&#xD;
          -  Physical or mental problems interfering with a outpatient visit&#xD;
&#xD;
          -  nonbioabsorbable cardiac stent&#xD;
&#xD;
          -  insufficient understanding of the Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>In order to be eligible the ovaries have been removed.</gender_description>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Flora E van Leeuwen, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>NKI-AvL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Netherlands Cancer Institute - Antoni van Leeuwenhoek</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 19, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>long-term</keyword>
  <keyword>premature ovarian insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835793
org study id: M18HAR
nct id: NCT03835793
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing
      salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/
      year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC)
      risk as well, due to reduced gonadal hormone levels. Besides favorable effects of RRSO on
      ovarian cancer and, potentially, BC risk, RRSO induces immediate menopause, which may have
      unfavorable long-term health consequences. Early menopause has been associated with increased
      risks of cardiovascular disease (CVD), lower bone mineral density (BMD), cognitive
      impairment, and decreased quality of life. Current evidence regarding these health effects is
      mainly based on women with a natural early menopause, and it is unknown whether these results
      hold for women undergoing RRSO at early premenopausal ages.

      Objective: The investigators will investigate long-term health effects of premenopausal RRSO
      on (subclinical) cardiovascular status, BMD, cognition and quality of life.

      Study design: the investigators will assess long-term health effects of RRSO in a
      cross-sectional study, among 500 women who underwent premenopausal RRSO compared to 250 women
      of the same age without RRSO (or with RRSO after age 55). Eligible women will be invited to
      participate in a screening program assessing cardiovascular status, bone mineral density,
      cognitive functioning and quality of life.

      Study population: Women are eligible for the premenopausal RRSO group if:

        -  RRSO before the age of 45 years;

        -  RRSO was done 10 or more years ago; Women are eligible for the comparison group without
           premenopausal RRSO if the participant did not undergo RRSO before the age of 55 years,
           and did not have a natural or therapy induced menopause before age 50.

      Primary study outcome: To study long-term effects of premenopausal RRSO on:

        -  (subclinical) CVD

        -  BMD

        -  Cognition

      Secondary study outcome: To study long-term effects of premenopausal RRSO on:

        -  Quality of life

        -  Urogenital problems

        -  Cardiovascular risk factors

      Furthermore, the investigators will examine the influence of age at RRSO, time since RRSO,
      hormone replacement therapy (HRT), carrier ship of a BRCA1 or BRCA2 mutation and BC history
      on the outcome.

      The obtained knowledge will assist physicians in counselling women with high ovarian cancer
      risk and help them to make well-informed decisions.
observational model: Cohort
time perspective: Cross-Sectional
measure: 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
time frame: 4 years
description: Due to the lack of estrogen we expect more atherosclerotic diseases.
measure: 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
time frame: 4 years
description: Due to the lack of estrogen we expect more atherosclerotic diseases.
measure: 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
time frame: 4 years
description: Due to the lack of estrogen we expect more atherosclerotic diseases.
measure: 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
time frame: 4 years
description: Due to the lack of estrogen we expect more atherosclerotic diseases.
measure: 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
time frame: 4 years
description: 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
measure: 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
time frame: 4 years
description: Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
measure: 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
time frame: 4 years
description: Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
measure: 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
time frame: 4 years
description: Loss of estrogen can result in more activity of osteoclasts and less activity of osteoblasts
measure: 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
time frame: 4 years
description: There are some studies suggesting that an early menopause has an influence on cognition
measure: 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
time frame: 4 years
description: 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
measure: 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.
time frame: 4 years
description: 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
measure: 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
time frame: 4 years
description: 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
measure: 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
time frame: 4 years
description: 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
measure: 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
time frame: 4 years
description: 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
measure: 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
time frame: 4 years
description: 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
measure: 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.
time frame: 4 years
description: Are some risk factors for cardiovascular disease more prevalent in women with a premenopausal RRSO
measure: 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.
time frame: 4 years
description: we will study the effect of RRSO on BC, contralateral breast cancer and ovarian cancer risk and prognosis after BC/ovarian cancer
arm group label: Early-RRSO
description: RRSO before the age of 45 years
RRSO was done 10 or more years ago
arm group label: Late-/non-RRSO group
description: Natural menopause ≥ 50 years of age
No RRSO ≤ age of 55
No treatment-induced menopause ≤ 50 years of age
intervention type: Diagnostic Test
intervention name: CAC-score
description: Testing for possible unfavourable health effects of early surgical menopause
arm group label: Early-RRSO
arm group label: Late-/non-RRSO group
other name: Blood sampling
other name: DXA-scan
other name: Vertebral Fracture Assessment
other name: Online cognition test (Amsterdam Cognition Scale)
other name: Quality of life questionnaire
Optional for studyparticipants is to collect and store DNA in a blood Biobank.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: In order to be eligible the ovaries have been removed.
minimum age: 55 Years
maximum age: N/A
last name: Flora E van Leeuwen, Phd
role: Principal Investigator
affiliation: NKI-AvL
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Cognitive Dysfunction
sharing ipd: Undecided