BRCA MutationBRCA_SFQ28NCT05456919
Quality of Sexual Function in BRCA Mutated Women
An observational study of BRCA Mutation and Sexual Dysfunction, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- BRCA Mutation, Sexual Dysfunction, Sexual Dysfunctions, Psychological
- What is being tested?
- SFQ28 Questionnaire
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2022to 15 Jul 2025
- 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 18 to 99 years
- Women only
- Adult, Older adult
Study population: TBC
Who may be able to join
- TBC
Who cannot join
- TBC
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Federico Ferrari
Brescia, BS, 25123
Federico Ferrari, PhD, 0303995341, federico.ferrari@unibs.it
Federico Ferrari, PhD
About this study
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.
Read the detailed description
We aim to investigate and compare the impact of diagnosis of BRCA, the impact of risk reducing surgery (RRS) and oncological diagnosis.
- Conditions
- BRCA Mutation, Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
- Being tested
- SFQ28 Questionnaire
- Keywords
- brca, sexual
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFQ28 QuestionnaireOther
SFQ28 Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| BRCA Mutated and no RRS | Not described Receives: Other: SFQ28 Questionnaire | |
| BRCA Mutated and RRS | Not described Receives: Other: SFQ28 Questionnaire | |
| BRCA Mutated and oncological diagnosis | Not described Receives: Other: SFQ28 Questionnaire | |
| BRCA Wildtype without oncological diagnosis | Not described Receives: Other: SFQ28 Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of SFQ28 Score
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA MutationStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Ferrari, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456919
- Sponsor's protocol ID
- BRCA_SFQ28
- Acronym
- BRCA_SFQ28
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Sexual Function in BRCA Mutated Women
- ClinicalTrials.gov ID
- NCT05456919
- Acronym / sponsor ID
- BRCA_SFQ28 / BRCA_SFQ28
- Conditions
- BRCA Mutation, Sexual Dysfunction, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
- Keywords
- brca, sexual
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 13 Jul 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.
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.
Detailed description
We aim to investigate and compare the impact of diagnosis of BRCA, the impact of risk reducing surgery (RRS) and oncological diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BRCA Mutated and no RRS | – | Other: SFQ28 Questionnaire |
| BRCA Mutated and RRS | – | Other: SFQ28 Questionnaire |
| BRCA Mutated and oncological diagnosis | – | Other: SFQ28 Questionnaire |
| BRCA Wildtype without oncological diagnosis | – | Other: SFQ28 Questionnaire |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- TBC
Key inclusion criteria (1 listed)
- TBC
Key exclusion criteria (1 listed)
- TBC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFQ28 QuestionnaireSFQ28 Questionnaire | Other | BRCA Mutated and RRS, BRCA Mutated and no RRS, BRCA Mutated and oncological diagnosis, BRCA Wildtype without oncological diagnosis |
Primary outcome
Measurement of SFQ28 Score
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- 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.
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 BRCA Mutation and Sexual Dysfunction, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 1 inclusion and 1 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 13 Jul 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of SFQ28 Score (time frame: At enrollment). 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 13 Jul 2022.