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

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • Federico Ferrari
        • Contact:
        • 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
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

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.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

Keywords

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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