Breast Cancer Registry to collate data on epidemiology and treatment patterns & outcomes of breast cancer in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 9
- 主要终点
- Proportions of new Breast Cancer patients
研究概览
简要总结
Breast cancer is the commonest cancer in women in urban India and accounts for about 25% to 33% of all cancers in women. Most of the risk factors and other features of breast cancer are usually identical round the world. However, each country has unique characteristics of cancer. e.g. about 50-55% of breast cancer cases were detected at late (III and IV) stage; in contrast to the 15% in US. Estrogen (ER) and HER2 are currently used in routine pathological assessment of breast cancer due to their predictive and prognostic role in management of breast cancer. Present Indian data is limited to few centers involved in population based cancer registry or of individual centers only. This may not reflect actual national incidence and frequencies of above mentioned aspects of breast cancer.
Objective
- To register new Breast Cancer patients and record their demographic, clinical and pathological features.
- To collate information on clinical course of the disease, treatment and after therapy follow-up.
- To collate the epidemiological data with emphasis on the biological markers in breast cancer
- To explore possibility to launch a national registry based on initial experience.
The data of breast cancer patient will be collected prospectively in new patients with the help of web based software or patient registry tool (PRT). Decisions related to treatment would be the choice of the treating doctor. Within a week of assessment/visit to OPD, the patient’s data from medical records will be entered using PRT. The registry will record the data available on demographics, relevant history, treatment given, recurrence and progression of disease, last follow up & death.
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
- All
入选标准
- •â€¢Newly diagnosed early breast cancer patients •Newly diagnosed metastatic breast cancer patients •Patient diagnosed as early breast cancer progressed to mBC and not treated for metastatic disease( i.e. first line mBC patients).
排除标准
- •â€¢2nd line metastatic breast cancer patients i.e. mBC patient treated earlier for their metastatic disease.
结局指标
主要结局
Proportions of new Breast Cancer patients
时间窗: 12 months
Proportions of patients with recurrence, progression of disease, survival and death
时间窗: 12 months
次要结局
- Proportions of patients with recurrence, progression of disease, survival and death(12 months)