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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be women 35-50 years old with a confirmed diagnosis of a deleterious BRCA 1/2 mutation recruited through UCSF.
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Jacoby, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37290104 | Derived | Chan LN, Chen LM, Goldman M, Mak JS, Bauer DC, Boscardin J, Schembri M, Bae-Jump V, Friedman S, Jacoby VL. Changes in Bone Density in Carriers of BRCA1 and BRCA2 Pathogenic Variants After Salpingo-Oophorectomy. Obstet Gynecol. 2023 Jul 1;142(1):160-169. doi: 10.1097/AOG.0000000000005236. Epub 2023 Jun 7. |
| Label | URL |
|---|---|
| BRCA 1 Studies at UCSF | View source |
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whole blood; serum; EDTA Plasma
| BRCA 2 Studies at UCSF | View source |