Prospective Research of Outcomes After Salpingo-oophorectomy

Completed

• Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation

• Registration Number: NCT01948609
• Lead Sponsor: University of California, San Francisco

Brief Summary

PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO.

The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2014-07
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• BRCA mutation 1/2 or "Variant suspected deleterious" mutation.
• Female
• Age 35-50 years
• Able to undergo RRSO
• Speaks English
• Able to give informed consent

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Exclusion Criteria

• Prior history of bilateral oophorectomy
• BRCA 1/2 deleterious mutation
• Plans to move out of geographic region in next 3 years
• Unable to travel to study visits

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.	Baseline to 36 Months	We will use dual-energy x-ray absorptiometry (DEXA) scan results and Intima-media thickness of the carotid artery (IMT) testing to assess changes in bone mineral density and carotid artery intima media thickness, respectively.
Change in baseline sexual functioning and quality of life at 36 months.	Baseline to 36 Months	We will use standard questionnaires to assess changes in overall quality of life and sexual function.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States