This trial is active, not recruiting.

Conditions brca1 gene mutation, brca2 gene mutation
Sponsor University of California, San Francisco
Collaborator American Cancer Society, Inc.
Start date July 2014
End date July 2018
Trial size 100 participants
Trial identifier NCT01948609, 13-11221


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Women with the BRCA gene 1/2 mutation who choose to undergo risk reducing salpingo-oophorectomy (RRSO) treatment.
Women with the BRCA gene 1/2 mutation who choose non-surgical treatment.

Primary Outcomes

Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.
time frame: Baseline to 36 Months
Change in baseline sexual functioning and quality of life at 36 months.
time frame: Baseline to 36 Months

Eligibility Criteria

Female participants from 35 years up to 50 years old.

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

Additional Information

Official title Prospective Research of Outcomes After Salpingo-oophorectomy
Principal investigator Vanessa Jacoby, MD, MAS
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by University of California, San Francisco.