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Favorable and unfavorable effects of risk-reducing salpingo-oophorectomy (RRSO) in women at high genetic risk of ovarian cancer

Favorable and unfavorable effects of risk-reducing salpingo-oophorectomy (RRSO) in women at high genetic risk of ovarian cancer - HARMOny (Health After eaRly Menopause due to Oophorecomy)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50443
Enrollment
750
Registered
2018-07-18
Start date
2019-02-08
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botgezondheid ovariectomy RRSO

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female patients High genetic risk of ovarian cancer Risk reducing salpingo-oophorectomy before the age of 46, or (for control group): High genetic risk for ovarian cancer Natural menopause after age of 50 years No RRSO before 55 years of age No treatment induced menopause before 50 years of age

Exclusion criteria

Exclusion criteria: For both groups: History of gynecological cancer at time of RRSO History of cancer at time of testing for BRCA-1 / BRCA-2 Ovariectomy for other reasons in patient history Cystectomy in patients history Metastatic disease Other serious comorbidity, psychiatric disorders, which would interfere with a clinic visit Not enough understanding of the Dutch language Non-bioresorbable cardiac stent Younger age than 55 years Premature Ovarian Insufficiency

Design outcomes

Primary

MeasureTime frame
We will assess long-term physical and mental health of 500 women who underwent premenopausal RRSO compared to 250 women of the same age without RRSO (or RRSO after the age of 55) in a cross sectional retrospective cohort study on - (subclinical)Cardiovascular disease - Bone mineral density - Cognitive functioning

Secondary

MeasureTime frame
Secondary parameters will be differences in the following factors between women with premenopausal RRSO and women without premenopausal RRSO: - Quality of life - Sexual functioning - Urogenital problems

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)