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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
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.


Condition or disease
BRCA1 Gene Mutation BRCA2 Gene Mutation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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
whole blood; serum; EDTA Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be women 35-50 years old with a confirmed diagnosis of a deleterious BRCA 1/2 mutation recruited through UCSF.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
American Cancer Society, Inc.
Investigators
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Principal Investigator: Vanessa Jacoby, MD, MAS University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01948609     History of Changes
Other Study ID Numbers: 13-11221
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018