A Prospective Evaluation of the Peri-operative Hypoxia in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Gene expression changes
研究概览
简要总结
To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during the surgery after partial devascularisation (sample B) and stored for future genomic and proteonomic evaluations.
详细描述
Three tumor samples will be obtained after the patient is under anaesthesia,
- Prior to starting surgery (Sample A)
- The middle intra-operative sample, which will be collected when half the tumour has been devascularized (i.e., somewhere midway during the surgery). (Sample B)
- A third post excision (anoxic sample C). These tumour tissue samples will be stored as snap frozen, in RNA later and as paraffin sections.
To understand the effects induced by acute hypoxia that sets in during surgery in breast cancer. To study this, clinical samples (Tumor biopsies) will be obtained during and stored for future genomic and proteonomic evaluations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Clinically diagnosis of breast cancer (by FNAC or Biopsy)
- •Not received any chemotherapy or surgical intervention except core biopsy.
- •Planed for Breast cancer surgery
- •Willing to give consent for the study
排除标准
- •Clinically diagnosis of Metastatic breast cancer
- •Received any anticancer therapy
结局指标
主要结局
Gene expression changes
时间窗: The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection.
The primary outcome measured will be gene expression changes during surgical resection. Messenger ribonucleic acid (mRNA) transcripts will be quantitated and their levels evaluated during different time-points of surgical resection, using high throughput omics technologies (Next generation sequencing, nanostring ncounter, qRT-PCR array).
次要结局
- Immunohistochemistry for other markers(The study aims to evaluate gene expression changes during surgical resection, which lasts for 30-90 minutes on an average. Thus, we have not planned a clinical follow-up or collection of data for the patients post sampling during surgical resection.)
研究者
Dr Rajendra A. Badwe
Director, Tata Memorial Centre and Professor, Department of Surgical Oncology
Tata Memorial Centre