Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2 (MATADOR2)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ayman AL SAATI, PharmD, PhD
- 전화번호: 0033 5 31 15 52 42
- 이메일: alsaati.ayman@iuct-oncopole.fr
연구 장소
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Toulouse, 프랑스, 31059
- Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique
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연락하다:
- Ayman AL SAATI, PharmD, PhD
- 전화번호: 0033 5 31 15 52 20
- 이메일: alsaati.ayman@iuct-oncopole.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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:
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
기간: 30 days approximately for each participant, 1 year and 1 month in total for all patients
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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.
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30 days approximately for each participant, 1 year and 1 month in total for all patients
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기타 결과 측정
결과 측정 |
기간 |
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The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis
기간: Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26 SEIN 02
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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