Breast Cancer Proteomics and Molecular Heterogeneity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,780
- 试验地点
- 6
- 主要终点
- Investigation of proteins and their pathways in primary breast cancer
研究概览
简要总结
Primary objective:
The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes
Secondary objective:
- To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.
- To relate proteomic findings to survival data
- To identify potential serum markers of breast cancer progression
详细描述
This is a translational study. Patient will undergo standard treatment and tissue and blood samples will be taken at various time points:
Tissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue.
Blood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid (EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no biopsy/surgery required then study bloods will be taken prior to starting treatment).
Additional blood samples will be taken annually at follow-up visits for 5 years from primary cases and for up to 2 years from recurrent/metastatic cases.
Non-heparinised blood will be processed to serum. Clinical data will be collected at all times of biological sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue
- •Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour tissue
- •Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage 4 breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue
- •Patients receiving neoadjuvant treatment are also eligible (if applicable)
- •Patients have to be ≥ 18 years of age
- •Patients must be able to give informed consent
排除标准
- 未提供
结局指标
主要结局
Investigation of proteins and their pathways in primary breast cancer
时间窗: 10 years
Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
次要结局
- Identification of novel molecular mechanisms of breast cancer recurrence(10 years)
- Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer(10 years)
- Determination of novel potential molecular targets(10 years)