Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene (LIFPREV)
Personalized Intervention to Reduce All Avoidable Cancer-promoting Exposures in Individuals at High Genetic Risk of Cancer Carrying a Constitutional Variant of the TP53 Gene
45% of cancer deaths are linked to modifiable factors (behavioral, metabolic). Li-Fraumeni syndrome (LFS), caused by germline TP53 mutations, leads to an extremely high, early-onset cancer risk (≈24× higher than general population).
Current surveillance programs are intensive but show no clear survival benefit; primary prevention is minimal.
Evidence suggests health behaviors (smoking, alcohol, diet, weight, physical activity) may influence cancer risk in TP53 carriers.
Early studies show frequent modifiable risk factors in this population (smoking, overweight/obesity, poor diet).
A major unmet need appears: current LFS care is currently focused almost solely on screening, without any other prevention measures.
This study aims to evaluate this participatory, multidimensional prevention program for germline TP53 carriers. If effective, it could be scaled nationally and internationally
研究概览
地位
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：Olivier CARON, MD
- 电话号码：+33142115178
- 邮箱：olivier.caron@gustaveroussy.fr
研究联系人备份
- 姓名：Tarek Ben-Ahmed, MD
- 电话号码：+33142112612
- 邮箱：tarek.ben-Ahmed@gustaveroussy.fr
学习地点
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Villejuif、法国、94805
- Gustave Roussy
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接触：
- Olivier CARON, MD
- 电话号码：+33142115178
- 邮箱：olivier.caron@gustaveroussy.fr
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接触：
- Tarek Ben-Ahmed, MD
- 电话号码：+33142112612
- 邮箱：tarek.ben-Ahmed@gustaveroussy.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult carriers of a pathogenic or likely pathogenic (class 4 or 5) germline variant in the TP53 gene.
- Free of active cancer, defined as cancer-free or having received no cancer treatment for more than one year, except hormone therapy for breast or prostate cancer.
- Attending the INTERCEPTION One-stop Prevention Clinic (OPC).
- Able to read and understand French.
- Agree to use their smartphone, including installation/use of the MyINTERCEPTION application and scanning QR codes to access study questionnaires.
Exclusion Criteria:
- Persons under guardianship or curatorship.
- Persons with currently active cancer or malignant disease.
- Persons currently receiving chemotherapy, radiotherapy, or targeted therapy for cancer. Hormone therapy for breast or prostate cancer is permitted.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 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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实验性的：Single Group Assignment
Participants will receive a personalized, multidimensional cancer prevention intervention integrated into the INTERCEPTION program, including assessment of modifiable cancer risk factors, educational and individualized counseling, a personalized prevention plan, digital follow-up through MyINTERCEPTION, and motivational telecoaching. |
Single Group Assignment |
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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Change in the composite Lifestyle Index at 1 year
大体时间：From baseline to follow up visit at 1 year
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Percentage of participants who achieve an improvement of at least 1 point in the composite Lifestyle Index between baseline and the 1-year follow-up visit (V2). The Lifestyle Index assesses exposure to modifiable cancer risk factors and is based on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) cancer prevention recommendations. |
From baseline to follow up visit at 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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-A01242-47
- CSET number 2026/4358 (其他标识符：Gustave Roussy)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data (IPD) will not be made publicly available. Study data will be pseudonymized and access will be restricted to authorized members of the study team in accordance with applicable data protection requirements.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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