LuCaReAl: Lung Cancer 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
- 897
- 试验地点
- 1
- 主要终点
- incidence of lung cancer
研究概览
简要总结
National, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria.
The study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.
详细描述
The study consists of:
- All patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study.
- The patients who do not consent will only be reported as new case of lung cancer for the incidence study.
The patients who consent to participate to the study will perform four in-hospital visits (Inclusion visit, visit at 3, 6 and 12 months). In addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the CRO or during a routine visit to the investigator, to check the patient's survival status.
THE STUDY DURATION 72 MONTHS
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
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist
- •Aged at least18 years at diagnosis
- •Patients who provide their informed consent form
排除标准
- •Patients who did not provide the informed consent form
- •Patients with a mental or psychological disorder according to their treating clinicians
结局指标
主要结局
incidence of lung cancer
时间窗: 12 months of recruitment period
incidence of lung cancer, all types, stages and ages combined, in men and women newly diagnosed with lung cancer in Algeria over 12 months of recruitment period
次要结局
- incidence of newly diagnosed lung cancer(12 month period)
- survival(at 12, 24, 36, 48 and 60 months of follow-up.)
- quality of life -EORTC QLQ-C30(baseline, 3, 6 and 12 months follow-up.)
- Quality Of Life-EORTC QLQ- LC13(baseline, 3, 6 and 12 months follow-up.)