Prospective Research of Outcomes After Salpingo-oophorectomy (PROSper)
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|ClinicalTrials.gov Identifier: NCT01948609|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : October 16, 2018
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 or disease|
|BRCA1 Gene Mutation BRCA2 Gene Mutation|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Research of Outcomes After Salpingo-oophorectomy|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Treated with RRSO
Women with the BRCA gene 1/2 mutation who choose to undergo risk reducing salpingo-oophorectomy (RRSO) treatment.
No RRSO treatment
Women with the BRCA gene 1/2 mutation who choose non-surgical treatment.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948609
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Vanessa Jacoby, MD, MAS||University of California, San Francisco|