BreCaReAl: Breast Cancers Registry in Algeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Survival status at 05 years (percentage of patients still alive at 05 years)
研究概览
简要总结
National, prospective, multicentre, non-interventional epidemiological study, conducted among oncologists and breast surgeons in community and university hospitals, from the public sector in Algeria.
The study will collect information on the characteristics, and breast carcinomas patterns of patients whose breast cancer diagnosis was confirmed by an anatomopathologist. The study will be conducted over a representative, but not exhaustive sample of Algerian female patients.
详细描述
The study consists of:
- Four in-hospital visits (inclusion visit, visit at 3 months, visit at 6 months, visit at 12 months). All patients presenting to their oncologists/breast surgeons during a routine visit and meeting eligibility criteria will be sequentially asked to participate to the study
- In addition to the 4 visits, a phone contact with the patients will be done by the investigator or the CRO (Clinical Research Organization, independent person) or during a routine visit to the investigator, to check the patients' survival every 6 months during 5 years (8 contacts).
Duration of patient recruitment: 6 months from the date of first patient's inclusion.
Duration of patient follow-up: 60 months 3.2 Data Source A comprehensive list of all Algeria hospitals will be used as a data source in the site selection process. The list will be obtained either from the health authority, local scientific societies or professional associations, depending on the local availability of this type of information. All efforts will be made to approach and select sites/physicians.
The oncologist/breast surgeons (investigator) or one of his/her authorised representative in each participating site will complete a CRF (Case Report Form). All data to be collected will be based on the patient's medical file.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible to participate to the study if they fulfil all of the following criteria:
- •Female patients
- •Aged 18 years and over
- •Newly diagnosed with breast cancer all stages confirmed during the study period by an anatomopathologist, defined as a first diagnosis of breast cancer based on anatomopathological results from at least a microbiopsy
- •Provision of subject informed consent.
排除标准
- •Patients will not be eligible to participate if any of the following criteria are present:
- •Informed consent not obtained.
- •Patients with a mental or psychological disorder according to their treating clinicians
- •Patients participating in an interventional study or already included in the study. A patient could be consulted and treated in two different centres, thus a codification system will be generated to avoid duplicate participation
结局指标
主要结局
Survival status at 05 years (percentage of patients still alive at 05 years)
时间窗: 60 months
Survival status at 60 months based on the percentage of patients still alive at 05 years
次要结局
- incidence all cases(06 months)
- Incidence by age(60 months)
- Incidence by stage(60 months)