- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05456919
Quality of Sexual Function in BRCA Mutated Women (BRCA_SFQ28)
July 10, 2022 updated by: Federico Ferrari, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BS
-
Brescia, BS, Italy, 25123
- Recruiting
- Federico Ferrari
-
Contact:
- Federico Ferrari, PhD
- Phone Number: 0303995341
- Email: federico.ferrari@unibs.it
-
Principal Investigator:
- Federico Ferrari, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
TBC
Description
Inclusion Criteria:
- TBC
Exclusion Criteria:
- TBC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
BRCA Mutated and no RRS
|
SFQ28 Questionnaire
|
|
BRCA Mutated and RRS
|
SFQ28 Questionnaire
|
|
BRCA Mutated and oncological diagnosis
|
SFQ28 Questionnaire
|
|
BRCA Wildtype without oncological diagnosis
|
SFQ28 Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of SFQ28 Score
Time Frame: At enrollment
|
At enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2022
Primary Completion (Anticipated)
July 15, 2024
Study Completion (Anticipated)
July 15, 2025
Study Registration Dates
First Submitted
July 10, 2022
First Submitted That Met QC Criteria
July 10, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 10, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRCA_SFQ28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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