Cardiovascular risk after risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers: CARSOBRA study

Completed

• Conditions: subclinical atherosclerosis; early signs of hardening of blood vessels; 10074469; 10003216

• Registration Number: NL-OMON42246
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Women carrying a BRCA1 or BRCA2 mutation
RRSO at age 45 or younger
RRSO performed at least five years ago

Exclusion Criteria

Women with (previous) ovarian cancer

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoints are CCA-IMT and PWV. Main study determinant is time since<br /><br>RRSO. Relevant covariates (confounding factors) are age, systolic blood<br /><br>pressure, medication use for blood pressure, smoking (pack-years of cigarette<br /><br>smoking and current smoking), insulin resistance, anti-diabetic medication use,<br /><br>fasting lipids, statin use, obstetric history of hypertensive disorders, family<br /><br>history of premature atherosclerosis (MI/stroke of first degree family: men <<br /><br>55 years, women < 65 years), body mass index, waist-hip ratio, physical<br /><br>activity, menopausal symptoms, current or previous use of hormone replacement<br /><br>therapy and a history of breast cancer treated with chemotherapy and/or<br /><br>radiotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>menopausal symptoms assessed with Greene Climacteric Scale</p><br>