Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Differential Gene Expression in Primary Tumor Tissue Associated With CNS Metastases
研究概览
简要总结
Breast cancer is the most common cancer in women. Although most patients are diagnosed at an early stage and treated with curative intent, some later develop metastases to the central nervous system (CNS), which are associated with poor prognosis and high morbidity. Currently, there are no validated biomarkers that reliably predict which patients with early-stage breast cancer are at increased risk for CNS metastases.
This study aims to identify molecular predictors of CNS metastases in early breast cancer. Gene expression profiles (mRNA) from archived primary tumor tissue will be analyzed using next-generation sequencing (NGS). In addition, serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8), measured at the time of diagnosis using ELISA, will be evaluated for their association with subsequent CNS metastases.
The results may improve risk stratification and support earlier identification of patients at increased risk for CNS spread.
详细描述
Breast cancer is frequently diagnosed at an early stage. Despite appropriate curative treatment, a subset of patients develops distant metastases during follow-up. Metastases to the central nervous system (CNS) represent a serious clinical complication due to their significant impact on morbidity and mortality. At present, no validated blood-based biomarkers are available to reliably predict CNS dissemination in patients with early-stage breast cancer.
The primary objective of this study is to identify genes that are differentially expressed in archived primary breast tumor tissue of patients who subsequently developed CNS metastases compared with matched controls who did not develop CNS metastases. Gene expression will be assessed using next-generation sequencing (NGS) of cDNA derived from mRNA.
The secondary objective is to evaluate whether baseline serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8), measured using enzyme-linked immunosorbent assay (ELISA), are associated with the later development of CNS metastases.
The study includes two clinically comparable groups of patients with early-stage breast cancer:
patients who developed CNS metastases during follow-up, and
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Female patients aged 18 years or older.
- •Diagnosis of early-stage breast cancer.
- •Availability of archived primary tumor tissue suitable for mRNA analysis.
- •Availability of serum sample suitable for chemokine analysis.
- •Patients included in the AKRA cohort with documented follow-up data.
- •Patients with confirmed CNS metastases during follow-up (CNS metastases group) or matched controls without CNS metastases (control group).
排除标准
- •Male breast cancer patients.
- •Lack of sufficient primary tumor tissue for mRNA analysis.
- •Lack of available serum sample for chemokine analysis.
- •Incomplete clinical follow-up data preventing classification of CNS metastasis status.
研究组 & 干预措施
CNS Metastases Group
Female patients with early-stage breast cancer who developed central nervous system (CNS) metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA.
干预措施: Primary Tumor mRNA Expression Profiling (NGS) (Diagnostic Test)
CNS Metastases Group
Female patients with early-stage breast cancer who developed central nervous system (CNS) metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA.
干预措施: Serum Chemokine Quantification (ELISA) (Diagnostic Test)
Control Group (No CNS Metastases)
Matched female patients with early-stage breast cancer who did not develop CNS metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA.
干预措施: Primary Tumor mRNA Expression Profiling (NGS) (Diagnostic Test)
Control Group (No CNS Metastases)
Matched female patients with early-stage breast cancer who did not develop CNS metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA.
干预措施: Serum Chemokine Quantification (ELISA) (Diagnostic Test)
结局指标
主要结局
Differential Gene Expression in Primary Tumor Tissue Associated With CNS Metastases
时间窗: Up to 36 months after baseline
Identification of genes differentially expressed in primary breast tumor tissue between patients who developed CNS metastases and matched controls without CNS metastases, assessed by mRNA expression profiling using NGS.
次要结局
- Association Between Baseline Serum Chemokine Concentrations and CNS Metastases(Up to 36 months after baseline)