Metastatic Breast Cancer in Austria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 16
- 主要终点
- Overall survival of patients with metastatic breast cancer in Austria
研究概览
简要总结
Breast cancer is the most common cancer among women worldwide. In Austria, this diagnosis is made more than 5000 times a year (STATISTICS AUSTRIA, Austrian Cancer Registry, as of 24.09.2012). Of these, already 5% to 10% have distant metastases at the time of initial diagnosis, and up to 30% of the node-negative tumours and up to 70% of the node-positive tumours metastasise at a later date. Metastatic breast cancer has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardised documentation of this disease. The aim of the registry is to answer both epidemiological and therapy-specific questions.
This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria. All tumour characteristics, medical histories and also treatment sequences are documented in anonymised form.
详细描述
The present AGMT registry will provide accurate documentation of initial disease progression and initial tumour characteristics in patients with metastatic breast cancer in Austria. The data collected will include: median age at metastasis, median disease-free survival (DFS) between initial diagnosis or first date of absence of disease and occurrence of metastasis, histological subtype of the primary tumour, initial TNM stage, grade and receptor status of the primary tumour, type and form of adjuvant therapy, pattern of metastasis and metastasis site. Characteristics that have a negative prognostic value are expected to be overrepresented in the metastatic patient group.
Also, this AGMT registry is intended to assess the distribution pattern of these metastatic stage subtypes in Austria. Additionally, their influence on treatment strategy and outcome is to be studied. Furthermore, the frequency and tumour characteristics of breast cancer in male patients will be assessed and the influence of gender on treatment strategies identified.
The AGMT breast cancer registry will conduct an exact analysis of survival data, thereby enabling accurate calculations of average survival duration in patients with metastatic breast cancer in Austria. Further parameters that reflect the quality or course of oncological treatment are the survival rates from the time of metastasis development at 1, 2 and 5 years after diagnosis.
This AGMT registry is intended to investigate the response to various therapies in a real life population in relation to previous treatments, concomitant diseases and breast cancer subtype. The aim is to assess which therapies are used at which time point and on which disease subtype they depend.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological evidence of breast cancer
- •Histological and/or radiological evidence of metastases
- •Metastasis within 10 years of registry initiation
- •Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent)
排除标准
- •Due to the non-interventional design of the registry there are no specific exclusion criteria.
结局指标
主要结局
Overall survival of patients with metastatic breast cancer in Austria
时间窗: 10 years
Number of patients with prognostic factors for metastatic breast cancer
时间窗: 10 years
Number of patients according to molecular subtypes
时间窗: 10 years
Frequency and tumour characteristics of breast cancer in male patients
时间窗: 10 years
次要结局
未报告次要终点