Prospective Research of Outcomes After Salpingo-oophorectomy

NCT01948609 | Completed

• 1 other identifier: 13-11221
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

BRCA1 Gene Mutation; BRCA2 Gene Mutation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 37290104 DERIVED

Related Links

• BRCA 1 Studies at UCSF
• BRCA 2 Studies at UCSF

Biospecimen

Retention: SAMPLES WITH DNA

whole blood; serum; EDTA Plasma

Study Officials

• Vanessa Jacoby, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 23, 2013
• Study Start: July 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)