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NCT01948609 Clinical Trial

Prospective Research of Outcomes After Salpingo-oophorectomy

BRCA1 Gene Mutation Clinical Trial

— PROSper  

Official title:
Prospective Research of Outcomes After Salpingo-oophorectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01948609
Other study ID # 13-11221
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date December 2021

Study information
Verified date September 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Francisco American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in risk of cardiovascular disease and osteoporosis at 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. Baseline to 36 Months
Primary Change in baseline sexual functioning and quality of life at 36 months. We will use standard questionnaires to assess changes in overall quality of life and sexual function. Baseline to 36 Months
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