Prospective Research of Outcomes After Salpingo-oophorectomy

N/ACompletedNCT01948609

University of California, San Francisco100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

BRCA1 Gene Mutation BRCA2 Gene Mutation

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 50 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Outcomes

Primary Outcomes

Change from baseline in risk of cardiovascular disease and osteoporosis at 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.

Time frame: Baseline to 36 Months

Change in baseline sexual functioning and quality of life at 36 months.

We will use standard questionnaires to assess changes in overall quality of life and sexual function.

Time frame: Baseline to 36 Months