Male breAsT cAncer preDisposition Factor

Breast Cancer Clinical Trial

— MATADOR  

Official title:

Male breAsT cAncer preDisposition Factor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219187
• Other study ID #: 23 SEIN 02
• Status: Recruiting
• Start date: February 8, 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Institut Claudius Regaud
• Contact: Christine TOULAS
• Phone: 05 31 15 52 20
• Email: toulas.christine[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Neoplasms, Male
• Disease Susceptibility

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	IUCT-O	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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