Prospective Research of Outcomes After Salpingo-oophorectomy (PROSper)

University of California San Francisco (UCSF)

Status: Completed

Conditions: BRCA2 Gene Mutation; BRCA1 Gene Mutation

Study type: Observational

Funder types: Other

Identifiers

NCT01948609

13-11221

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Treated with RRSO

Description:

Women with the BRCA gene 1/2 mutation who choose to undergo risk reducing salpingo-oophorectomy (RRSO) treatment.

No RRSO treatment

Description:

Women with the BRCA gene 1/2 mutation who choose non-surgical treatment.