Circulating Tumor Cells as Biomarker for Monitoring Treatment Response After Surgery in Early Breast Cancer Patients Towards Improving Patients Well Being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Fall in CTC after Surgical intervention in Breast Cancer Patients , Reduction in cancer worry as Patient reported outcome measure after surgery, Minimum Residual Disease burden will be reduced there b y improving the survival of breast cancer patients.
研究概览
简要总结
Breast cancer is one of the most common cancers globally and a leading cause of cancer-related mortality in India, with an incidence rate of 25–30 per 100,000 women in urban areas and 10–15 per 100,000 in rural areas. Metro cities such as Hyderabad, Delhi, Mumbai, and Bangalore are the most affected, with Indian women being diagnosed nearly 10 years earlier than their Western counterparts, typically between 40–50 years of age. Alarmingly, around 60% of breast cancer cases in India are diagnosed at an advanced stage (Stage III/IV), leading to poor outcomes, with the 5-year survival rate being only 66%. Contributing factors include lack of awareness, late detection, and limited access to healthcare services. Early treatment response monitoring is essential for improving clinical outcomes and guiding personalized care. Currently, imaging remains the primary tool to assess treatment response, disease progression, and recurrence risk; however, as breast cancer is a systemic disease, cancer cells may be circulating in the blood much earlier than changes are detectable on imaging. Circulating Tumor Cells (CTCs), which are shed from primary tumors into the bloodstream, are emerging as promising biomarkers, capable of providing real-time insights into treatment response, disease progression, and recurrence risk. Evaluating the role of surgery in reducing systemic tumor burden using CTCs as biomarkers can help optimize systemic treatment planning in early breast cancer patients. This study aims to investigate the role of CTCs as biomarkers in breast cancer patients undergoing surgery to assess tumor burden reduction post-surgery and to understand patient-reported outcome measures (PROM) related to cancer worry, thereby contributing towards improving patient well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Male and female breast cancer patients 2.Patients undergoing Breast conservation surgery, Modified radical mastectomy or Simple mastectomy 3.Patients undergone neoadjuvant chemotherapy 4.Ductal & Lobular carcinoma – In situ or Invasive.
排除标准
- •1.Second surgery 2.Recurrent disease 3.Metastatic disease 4.Benign breast lumps, sarcoma.
结局指标
主要结局
Fall in CTC after Surgical intervention in Breast Cancer Patients , Reduction in cancer worry as Patient reported outcome measure after surgery, Minimum Residual Disease burden will be reduced there b y improving the survival of breast cancer patients.
时间窗: 1.Baseline (Pre-surgery): | First CTC blood sample collection (to establish baseline CTC count). | Assessment of cancer worry (Patient Reported Outcome Measure – PROM). | 2.24 hours post-surgery: | Second CTC blood sample collection. | Assessment in cancer worry (PROM).
次要结局
- NIll(NIll)
研究者
Dr Rakesh S Ramesh
St Johns Medical college Hospital, Bengaluru
