Male breAsT cAncer preDisposition Factor

NCT06219187 | Completed

• 1 other identifier: 23 SEIN 02
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; PreDisposition factor

Outcome Measures

Primary Outcomes (2)

• The environmental data in the questionnaire will be described by the usual descriptive statistics.

  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.

  15 days for each patient

• Psychosocial data from the questionnaire will be described using standard descriptive statistics.

  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.

  15 days for each patient

Study Arms (1)

Male breast cancer

Other: Questionnaire completion

Interventions

Questionnaire completion 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

Male breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a history of male breast cancer (MBC) referenced in the IUCT-O's regional MutaFamily-MBC database.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

IUCT-O

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: February 8, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

FR (1)