Personalised Breast Cancer Program- India (PBCP-I)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Main outcome:
研究概览
简要总结
Patients recruited to this Pilot study will have the whole genome of the tumor and cells sequenced and data stored in database. Treatment, demographic and clinical outcomes data will be collected and then clinical outcomes followed up for a minimum of 3 years (or until death) and correlated with the molecular profiles generated. The whole genome sequencing (WGS) data generated will allow classification into both prognostic risk groups and also potentially identify molecular drivers of breast cancer (e.g. CCND1, PAK1, ERBB2) and molecular profiles predictive of treatment response or non-response. We will store the RNA during the lifetime of the study from the patients where genome is sequenced, and we will explore the feasibility of including these results in clinical reports at a later stage. We will also investigate mutation signatures associated with prediction of treatment response to chemotherapy and also targeted agents.
This will be a single-centre study in Tata Medical Center, Kolkata with a sample size of 200 patients with breast cancer. Patients will be followed-up for a minimum of 5 years (or until death) from the date they receive their genomic results.
The primary objective is to evaluate the clinical feasibility and clinical utility of Whole Genome Sequencing (WGS) in the clinical management of breast cancer patient, in real world setting
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •To be included in the trial the patient must: 1.Have given written informed consent to participate for the study according to national/local regulations
- •Be aged over 18 years’ old
- •ECOG performance status 0, 1 or 2
- •Patient with histological diagnosis of AJCC Stage 1, 2, 3 or 4 invasive breast cancer (the presence of high grade DCIS is acceptable), including new loco-regional relapse or new metastatic lesion.
- •Patients scheduled for a biopsy/surgical procedure of the new lesion or fresh tissue available for research.
排除标准
- •Presence of any psychological, family, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
结局指标
主要结局
Main outcome:
时间窗: 5 years
Proportion of patients that receive personalised treatment based on genomic results.
时间窗: 5 years
次要结局
- 1.To evaluate the impact of genome-driven personalised medicine on breast cancer outcomes at 3 years in a non-selective, real-world setting.(2.To assess the effect of a genomic profiling programme on the identification of patients for clinical trials inclusion in a breast cancer population of all stages of disease.)
研究者
Dr Sanjoy Chatterjee
Tata Medical Centre, Kolkata