NCT06792721招募中不适用
EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION
Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparing the mutational burden in a person genetically predisposed to cancer with that of a non-predisposed relative
研究概览
简要总结
Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer
详细描述
This proof-of-concept trial will be conducted with family members being monitored for a predisposition to breast and/or ovarian cancer linked to a BRCA1/2 gene mutation.
The study will be proposed to two sisters from the same sibling:
- one is a carrier of the genetic mutation
- and the other not,
Blood tests will evaluate the Mutation Burden cfMB
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participant
- •Participant undergoing oncogenetic follow-up at the Centre François Baclesse
- •Participant belonging to a pair of related biological siblings
- •Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control).
- •Participant between 30 and 50 years of age
- •Participant affiliated to a social security scheme
- •Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.
排除标准
- 未提供
结局指标
主要结局
Comparing the mutational burden in a person genetically predisposed to cancer with that of a non-predisposed relative
时间窗: At the enrollment in the study (one point)
Measurement and quantification of genomic signature on circulating DNA (mutational burden) derived from whole blood in a carrier of the genetic mutation and in her non-carrier first-degree relative.
次要结局
- Mutation profiling, COSMIC-type signature generation(At the enrollment in the study (one point))
- Identify and evaluate complementary or alternative molecular signatures(At the enrollment in the study (one point))
研究者
研究点 (1)
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