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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics. [Срок оценки: 30 days approximately for each participant, 1 year and 1 month in total for all patients]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

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

Идентификаторы

NCT: NCT07558343 · 26 SEIN 02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗