Intratumoral Microbiota in Breast Cancer: A Prospective Discovery Study Integrating Tumor/Adjacent Normal Tissue, Estrobolome, and Gut Microbiota Analyses, With Stratification by Molecular Subtypes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Breast cancer-associated microbial signatures
研究概览
简要总结
Study on patients undergoing surgery for breast cancer. Objective: to characterize the intratumoral microbiota and integrate these findings with clinicopathologic data, the estrobolome, and gut microbiota, with analyses stratified by molecular subtype (Luminal A, Luminal B, HER2-enriched [human epidermal growth factor receptor 2-enriched], and TNBC [triple-negative breast cancer]).
Enrollment: consecutive recruitment in the operating room based on the availability of biopsy/histological material.
Samples: tumor tissue, adjacent normal tissue; urine (for indirect assessment of estrobolome activity); and stool. Strict anti-contamination measures will be implemented.
Exploratory outcomes: differences across subtypes, associations with features of the TME (tumor microenvironment), including TILs (tumor-infiltrating lymphocytes), and markers of progression or treatment resistance
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years with primary, non-metastatic breast cancer (BC) undergoing surgery.
- •Availability of sufficient tumor and adjacent normal tissue for research purposes after completion of diagnostic sampling.
- •Written informed consent
排除标准
- •Active systemic infection or fever >38.0°C within 72 h pre-surgery.
- •Antibiotics within 14 days pre-sampling (recorded; analyses adjusted).
- •Prior ipsilateral BC surgery for current lesion (except re-excision with fresh tissue).
- •Any condition preventing compliance with the study protocol.
研究组 & 干预措施
Patients undergoing surgery for breast cancer
single-arm discovery study with consecutive enrollment of eligible patients undergoing surgery for primary breast cancer
干预措施: Surgery for breast cancer (Procedure)
结局指标
主要结局
Breast cancer-associated microbial signatures
时间窗: 12 months
To characterize intratumoral microbial signatures (composition and inferred function) across breast cancer (BC) molecular subtypes (Luminal A, Luminal B, HER2-enriched, TNBC) using contamination-aware pipelines
次要结局
- Comparison of microbial signatures(12 months)
- Association between microbial and host features(12 months)