BRCA1 Gene Mutation, BRCA2 Gene Mutation
Conditions
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.
Interventions
None listed
Sponsors
American Cancer Society, Inc.
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed