Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2
ConditionMale Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age66+
SponsorInstitut Claudius Regaud
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Questionnaire completion
Other interventionIn 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 interventionIn 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Control groupOther 2 interventions
Trial outcomes
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.
Time frame
30 days approximately for each participant, 1 year and 1 month in total for all patientsOther 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 yearSponsors and contacts
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Institut Claudius Regaud
Lead sponsor
Ligue contre le cancer, France
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: