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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ayman AL SAATI, PharmD, PhD
- 电话号码：0033 5 31 15 52 42
- 邮箱：alsaati.ayman@iuct-oncopole.fr
学习地点
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Toulouse、法国、31059
- Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique
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接触：
- Ayman AL SAATI, PharmD, PhD
- 电话号码：0033 5 31 15 52 20
- 邮箱：alsaati.ayman@iuct-oncopole.fr
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
大体时间：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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其他结果措施
结果测量 |
大体时间 |
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The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis
大体时间：Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.