NCT01484483已完成不适用
Breast Cancer Care (BRECC) Registry - Development of a Breast Cancer Registry to Determine the Magnitude of Breast Cancer and Current Clinical Care Patterns in Kenya
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of breast cancer in Kenya
研究概览
简要总结
This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Histologically or cytologically confirmed breast cancer
- •No previous interventional therapy for breast cancer
- •Ability to provide written informed consent as per GCP and local regulations
排除标准
- •Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment
- •Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse
结局指标
主要结局
Incidence of breast cancer in Kenya
时间窗: 5 years
Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya
时间窗: 5 years
次要结局
- Progression-free survival(5 years)
- Overall survival(5 years)
- Pathology: Prevalence of tumour types(5 years)
- Patient demographics of breast cancer patients in Kenya(5 years)
- Correlation between risk factors and clinical outcome(5 years)
- Therapy duration/compliance(5 years)
- Safety: Incidence of adverse events(5 years)
研究者
研究点 (1)
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