跳至主要内容
临床试验/NCT06876610
NCT06876610招募中不适用

Application of CfDNA Methylation Detection in Auxiliary Diagnosis of Breast Cancer

Geneplus-Beijing Co. Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.

研究概览

简要总结

The purpose of this study is to construct an auxiliary diagnostic model for breast cancer by methylation markers. The study will collect blood and tissue samples from participants with breast cancer and benign disease for whole-genome methylation sequencing. It will screen methylation markers and develop a methylation auxiliary diagnosis model to distinguish between breast cancer and non-cancer.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Establish DNA methylation profiles of two populations by collecting tissues and peripheral blood related to benign and malignant breast nodules.

时间窗: 12 months

Based on DNA methylation profiles, systematically evaluate the signal, noise, and complementarity of methylation biomarkers and ultimately form a set of diagnostic biomarker combinations for breast malignant nodules.

时间窗: 12 months

Further develop a methylation assisted diagnostic model that can effectively distinguish between benign and malignant breast nodules.

时间窗: 12 months

次要结局

  • Evaluate the contribution and performance of methylation assisted diagnostic models by integrating imaging and methylation assisted diagnostic model results, and clarify the specificity and sensitivity of integrated model diagnosis.(12 months)

研究者

发起方
Geneplus-Beijing Co. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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