Male breAsT cAncer preDisposition Factor

NCT ID: NCT06219187

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2025-02-06

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Male breast cancer

Questionnaire completion

Intervention Type: OTHER

To meet the study's objective, patients will be asked to complete a questionnaire characterizing their environmental and psychosocial context.

The questionnaire is to be completed by the patients themselves, or by their trusted support person as recorded in their medical records (in the particular case of a deceased patient).

It is estimated that the questionnaire will take around 30 minutes to complete.

Data will also be collected from the medical records of included patients:

• Demographics
• Disease data

Interventions

Questionnaire completion

To meet the study's objective, patients will be asked to complete a questionnaire characterizing their environmental and psychosocial context.

The questionnaire is to be completed by the patients themselves, or by their trusted support person as recorded in their medical records (in the particular case of a deceased patient).

It is estimated that the questionnaire will take around 30 minutes to complete.

Data will also be collected from the medical records of included patients:

• Demographics
• Disease data

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IUCT-O

Toulouse, , France

Countries

France

Other Identifiers

23 SEIN 02

Identifier Type: -

Identifier Source: org_study_id