NCT02663973已完成不适用
Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 24
- 主要终点
- Description of the epidemiology of breast cancer in the Brazilian population
研究概览
简要总结
The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population
详细描述
The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population. Other specific goals are:
- To evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history.
- Characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, HER2, Ki67.
- Describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis.
- Describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy.
- Describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others.
- Evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan.
- Evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events.
- Analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Woman ≥ 18 years old
- •Invasive breast cancer stage I to IV proven by histology or cytology
- •Patients with new pathological diagnosis of invasive primary BC after the site activation date
- •Pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included)
- •New primary cancer on the same breast or contralateral breast.
- •Patient's medical chart is available and adequate for data collection
- •Patient properly signed the informed consent form
排除标准
- 未提供
结局指标
主要结局
Description of the epidemiology of breast cancer in the Brazilian population
时间窗: Annually, during 5 years
次要结局
- Characterization of the immunophenotypic markers of the tumor(Annually, during 5 years)
- Initial treatment for breast cancer of Brazilian patients(Annually, during 5 years)
- Main symptoms presented by patients with breast cancer in Brazil(Annually, during 5 years)
- Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients(Annually, during 5 years)
- Types of clinical complications displayed by breast cancer Brazilian patients(Annually, during 5 years)
- Description of the socioeconomical characteristics of the Brazilian population with breast cancer(Annually, during 5 years)
- Classification of breast cancer staging(Annually, during 5 years)
- Description of screening tests of breast cancer patients in Brazil(Annually, during 5 years)
- Clinical outcome of Brazilian breast cancer patients(Annually, during 5 years)
- Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients(Annually, during 5 years)
研究者
研究点 (24)
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