BRCA_SFQ28: Quality of Sexual Function in BRCA Mutated Women
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05456919
Collaborator
(none)
300
1
36
8.3
Study Details
Study Description
Brief Summary
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational
Anticipated Enrollment
:
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Quality of Sexual Function in BRCA Mutated Women
Anticipated Study Start Date
:
Jul 15, 2022
Anticipated Primary Completion Date
:
Jul 15, 2024
Anticipated Study Completion Date
:
Jul 15, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BRCA Mutated and no RRS
|
Other: SFQ28 Questionnaire
SFQ28 Questionnaire
|
| BRCA Mutated and RRS
|
Other: SFQ28 Questionnaire
SFQ28 Questionnaire
|
| BRCA Mutated and oncological diagnosis
|
Other: SFQ28 Questionnaire
SFQ28 Questionnaire
|
| BRCA Wildtype without oncological diagnosis
|
Other: SFQ28 Questionnaire
SFQ28 Questionnaire
|
Outcome Measures
Primary Outcome Measures
- Measurement of SFQ28 Score [At enrollment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
- TBC
Exclusion Criteria:
- TBC
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federico Ferrari | Brescia | BS | Italy | 25123 |
Sponsors and Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Federico Ferrari,
Research Associate,
Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT05456919
Other Study ID Numbers:
- BRCA_SFQ28
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Federico Ferrari,
Research Associate,
Università degli Studi di Brescia
Additional relevant MeSH terms: