Male Breast Cancer
Conditions
Keywords
breast cancer, predisposition factor
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.
Interventions
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.
OTHERGenetic analysis (WES)
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.
Sponsors
Institut Claudius Regaud
Ligue contre le cancer, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
MALE
Age
66 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics. | 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. |
Countries
France
Contacts
CONTACTAyman AL SAATI, PharmD, PhD
Outcome results
None listed