Prospective Research of Outcomes After Salpingo-oophorectomy

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.

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Key information

Conditions

BRCA1 Gene Mutation BRCA2 Gene Mutation

Age range

35 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.

Time frame: 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.

Time frame: Baseline to 36 Months

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

American Cancer Society, Inc.

Registry information

Acronym: PROSper

Important dates

Study start: 2014
Primary completion: 2021
Study completion: 2021
First posted: Sep 23, 2013
Registry last updated: Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed