Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2

NCT07558343 | Not Yet Recruiting

• 1 other identifier: 26 SEIN 02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer. The study will be conducted on a population of 120 participants.

Conditions

Male Breast Cancer

Keywords

breast cancer; predisposition factor

Outcome Measures

Primary Outcomes (1)

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

  A 75-question questionnaire (created for the purposes of the MATADOR project) will cover such aspects as the participant's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. For each question of the questionnaire: quantitative variables will be described by the median, minimum, maximum and number of missing data, and qualitative variables by the numbers, percentages and number of missing data.

  30 days approximately for each participant, 1 year and 1 month in total for all patients

Other Outcomes (1)

• The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis

  Through study completion, an average of 1 year

Study Arms (1)

Control group

OTHER

The participants enrolled in this study (MATADOR2) will serve as control group for the patients enrolled in the previous study (MATADOR = MATADOR1) in order to identify: 1. the environmental and psychosocial predisposition factors 2. the genetic predisposition factors

Other: Questionnaire completion; Other: Genetic analysis (WES)

Interventions

Questionnaire completion OTHER

In order to meet the study's objective, after written informed consent was obtained, participants will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be filled out by the participants at home. It is estimated that the questionnaire will take around 30 minutes to complete. Demographics data will also be collected from the medical records of included participants.

Control group

Genetic analysis (WES) OTHER

In order to meet the study's objective, after completion of the questionnaire, a genetic analysis (Whole Exome Sequencing) will be conducted on an archived blood sample collected during the initial oncogenetics consultation. The patient had given consent to this sample in order for the oncogenetics laboratory to perform the targeted genetic analysis (presence of family mutation). No additional blood sample will be collected for the purpose of this study.

Control group

Eligibility Criteria

• Age: 66 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. A male volunteer participant with no personal history of cancer, registered in the IUCT-O oncogenetics database as a relative of a patient carrying a pathogenic or likely pathogenic variant in one of the cancer predisposition genes routinely analyzed at the oncogenetics laboratory
• \. Age ≥ 66 years
• \. Participant with no known family relationship to a patient of the MATADOR1 cohort
• \. Participant who has undergone an oncogenetic consultation at the IUCT-O
• \. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested
• \. Participant for which an archived blood sample is available for the research in the oncogenetics laboratory

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)

Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Ayman AL SAATI, PharmD, PhD

CONTACT

0033 5 31 15 52 42; alsaati.ayman@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is intended to serve as a control group for the MATADOR study (=MATADOR1) which was conducted on patients presenting with male breast cancer (MBC). Their environmental and psychosocial background was studied through the completion of a questionnaire. In this study (MATADOR2), the participants were free of cancer at the time of the oncogentic consultation and did not present the family mutation (on the MBC predisposition genes routinely tested in oncogenetic consultation). In this control group, the participants will complete the same questionnaire as the MATADOR1 patients. In addition, the genetic predisposition factors will be analyzed through genetic analysis (Whole Exome Sequencing).

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)