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NCT Number: NCT07558343

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

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.

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Key information

Conditions

Male Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

66 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, 31059, France

Location contact

Ayman AL SAATI, PharmD, PhD

CONTACT

[email protected]

0033 5 31 15 52 20

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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
  • 2. Age ≥ 66 years
  • 3. Participant with no known family relationship to a patient of the MATADOR1 cohort
  • 4. Participant who has undergone an oncogenetic consultation at the IUCT-O
  • 5. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested
  • 6. Participant for which an archived blood sample is available for the research in the oncogenetics laboratory
  • 7. Participant having signed an informed consent form before inclusion in the study and before any study specific procedure

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).

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

Other outcomes

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

    Time frame: Through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman AL SAATI, PharmD, PhD

CONTACT

[email protected]

0033 5 31 15 52 42

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Acronym: MATADOR2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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