Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 66 Years to — (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Control group
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:
- the environmental and psychosocial predisposition factors
- the genetic predisposition factors
Intervention: Questionnaire completion (Other)
Control group
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:
- the environmental and psychosocial predisposition factors
- the genetic predisposition factors
Intervention: Genetic analysis (WES) (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported