Male breAsT cAncer preDisposition Factor

Completed

• Conditions: Breast Cancer
• Interventions: Other: Questionnaire completion

• Registration Number: NCT06219187
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.

The study will be conducted on a population of 110 to 150 patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Study Start: 2024-02-08
• Status Verified: 2025-02
• Primary Completion: 2025-02-06
• Study Completion: 2025-02-06
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 93

Inclusion Criteria

1. Male patient with a personal history of breast cancer
2. Age ≥ 18 years
3. Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
4. Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
5. Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).

Exclusion Criteria

1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male breast cancer	Questionnaire completion	-

Primary Outcome Measures

Name	Time	Method
Psychosocial data from the questionnaire will be described using standard descriptive statistics.	15 days for each patient	A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.; Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
The environmental data in the questionnaire will be described by the usual descriptive statistics.	15 days for each patient	A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.; Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.

Trial Locations

Locations (1)

IUCT-O; 🇫🇷 Toulouse, France