NCT05456919

Brief Summary

Quality of sexual function in BRCA mutated women is investigated using SFQ28 questionnaire.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 10, 2022

Last Update Submit

July 10, 2022

Conditions

BRCA MutationSexual DysfunctionSexual Dysfunctions, PsychologicalSexual Dysfunction, Physiological

Keywords

brcasexual

Outcome Measures

Primary Outcomes (1)

  • Measurement of SFQ28 Score

    At enrollment

Study Arms (4)

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

Interventions

SFQ28 QuestionnaireOTHER

SFQ28 Questionnaire

BRCA Mutated and RRSBRCA Mutated and no RRSBRCA Mutated and oncological diagnosisBRCA Wildtype without oncological diagnosis

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

TBC

You may qualify if:

  • TBC

You may not qualify if:

  • TBC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico Ferrari

Brescia, BS, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalCoitus

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMental DisordersSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

July 10, 2022

First Posted

July 13, 2022

Study Start

July 15, 2022

Primary Completion

July 15, 2024

Study Completion

July 15, 2025

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)