Menu
Not yet recruiting NCT07558343

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

No phase Interventional Male Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire completion, Genetic analysis (WES).
Who it may be relevant to
Registry conditions: Male Breast Cancer. Basic parameters: from 66 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Questionnaire completion
    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.
  • Other Genetic 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.

Primary outcome measures

  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique — Toulouse

Identifiers

NCT: NCT07558343 · 26 SEIN 02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗