BRCA1 Gene MutationPROSperNCT01948609
Prospective Research of Outcomes After Salpingo-oophorectomy
An observational study of BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJul 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BRCA1 Gene MutationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948609
- Sponsor's protocol ID
- 13-11221
- Acronym
- PROSper
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2013
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37290104
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Research of Outcomes After Salpingo-oophorectomy
- ClinicalTrials.gov ID
- NCT01948609
- Acronym / sponsor ID
- PROSper / 13-11221
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jul 2014
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- BRCA mutation 1/2 or "Variant suspected deleterious" mutation.
- Female
- Age 35-50 years
- Able to undergo RRSO
- Speaks English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 37290104Chan 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.
- BRCA 1 Studies at UCSFLink provided by the sponsor.
- BRCA 2 Studies at UCSFLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Jacoby, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months. (time frame: Baseline to 36 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.