Hereditary Breast and Ovarian CancerBRCA-HRTNCT05409222
Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)
An observational study of Hereditary Breast and Ovarian Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT. 2. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women only
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2020to Oct 2023
- 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 30 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women identified and followed at the Hospital de la Santa Creu i Sant Pau.
Who may be able to join
- Age between 30 and 49 years
- Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation.
Who cannot join
- Personal history of oophorectomy for benign or malignant ovarian pathology.
- Personal history of breast cancer.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Teresa Ramon y Cajal, MD PhD, +34935565638 ext. 5634, tramon@santpau.cat
Nuria Calvo, MD, +34935565638, ncalvo@santpau.cat
About this study
Official title: Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers
- Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT.
- Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT.
- Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.
- Conditions
- Hereditary Breast and Ovarian Cancer
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
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 |
|---|---|---|
| Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy | Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy | |
| Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy | Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy | |
| Cohort 2: without preventive salpingo-oophorectomy | Healthy carriers who decide not to proceed to preventive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy
Questionnaire to measure quality of life in post-menopausal women (the Mencav questionnaire). This questionnaire consists of questions with 5 possible answers, answer 1 is the worst result and question 5 is the best result, so low scores mean worse results and high scores better results.
Measured: 5 years
Secondary outcomes (8)
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
To describe cardiovascular risk we used changes in the weight of patients. Weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2.
Measured: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
To describe cardiovascular risk we used changes in blood pressure (mmHg)
Measured: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
To describe cardiovascular risk we used changes in lipids levels (cholesterol, triglycerides, HDL, LDL and VLDL)
Measured: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
To describe cardiovascular risk we used eventual cardiovascular adverse events
Measured: 5 years
To compare the impact of hormone replacement therapy on number and description of bone loss related events in premenopausal carriers after salpingo-oophorectomy we will perform bone densitometry
By performing bone densitometry we will be able to quantify the number of participants with adverse events related to bone loss (osteoporosis or osteopenia)
Measured: 5 years
Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it.
We will analyze and compare the mean of overall survival of women undergoing for risk-reducing surgery and those rejecting it
Measured: 5 years
Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery.
We will analyze and compare the mean of breast cancer specific survival in women undergoing surgery and those rejecting it.
Measured: 5 years
Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it.
We will analyze and compare the mean of gynecologic cancer survival of women undergoing surgery and those rejecting it.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start12 Mar 2020
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Breast and Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Ramon y Cajal, MD PhD, Principal investigator, Hospital Santa Cruz y San Pablo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409222
- Sponsor's protocol ID
- IIBSP-ECV-2019-103
- Acronym
- BRCA-HRT
- Status last verified
- Jun 2022
- First submitted
- 13 Mar 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers
- ClinicalTrials.gov ID
- NCT05409222
- Acronym / sponsor ID
- BRCA-HRT / IIBSP-ECV-2019-103
- Conditions
- Hereditary Breast and Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- 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.
- Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT.
- Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT.
- Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy | – | –Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy |
| Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy | – | –Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy |
| Cohort 2: without preventive salpingo-oophorectomy | – | –Healthy carriers who decide not to proceed to preventive surgery |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women identified and followed at the Hospital de la Santa Creu i Sant Pau.
Key inclusion criteria (2 listed)
- Age between 30 and 49 years
- Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation.
Key exclusion criteria (2 listed)
- Personal history of oophorectomy for benign or malignant ovarian pathology.
- Personal history of breast cancer.
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
To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy
Time frame: 5 years
Questionnaire to measure quality of life in post-menopausal women (the Mencav questionnaire). This questionnaire consists of questions with 5 possible answers, answer 1 is the worst result and question 5 is the best result, so low scores mean worse results and high scores better results.
8 secondary outcomes
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
Time frame: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
Time frame: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
Time frame: 5 years
To compare the impact of hormone replacement therapy on number and description of cardiovascular events
Time frame: 5 years
To compare the impact of hormone replacement therapy on number and description of bone loss related events in premenopausal carriers after salpingo-oophorectomy we will perform bone densitometry
Time frame: 5 years
Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it.
Time frame: 5 years
Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery.
Time frame: 5 years
Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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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.
Teresa Ramon y Cajal, MD PhD principal investigator
Hospital Santa Cruz y San Pablo
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 Hereditary Breast and Ovarian Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jun 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Ramon y Cajal, MD PhD (+ 34 93 556 56 38 ext. 5634, tramon@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2022.