clinical trial: Prospective Research of Outcomes After Salpingo-oophorectomy - BRCA1/2 (PROSper)

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This study is not yet open for participant recruitment.

Verified September 2013 by University of California, San Francisco

Sponsor:

University of California, San Francisco

Collaborator:

American Cancer Society, Inc.

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01948609

First received: September 12, 2013

Last updated: September 18, 2013

Last verified: September 2013

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  Purpose

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.

Condition
BRCA1 Gene Mutation BRCA2 Gene Mutation

 

Study Population

Study participants will be women 35-50 years old with a confirmed diagnosis of a deleterious BRCA 1/2 mutation recruited through UCSF.

Criteria

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