Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,657
- 主要终点
- Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers
排除标准
- •Age under 18 years at time of diagnosis
结局指标
主要结局
Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Approximately 2 years
Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Approximately 2 years
Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Approximately 2 years
Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Percent of patients with an adverse event (AE)
时间窗: Approximately 2 years
Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Approximately 2 years
Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Approximately 2 years
Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients
时间窗: Approximately 2 years
Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease
次要结局
- Drug utilization after NSCLC diagnosis by line of therapy(Approximately 2 years)
- Smoking habits of NSCLC patients at diagnosis(At baseline visit)
- Proportion of patients who receive surgery by stage at treatment(Approximately 2 years)
- Age of NSCLC patients at diagnosis(At baseline visit)
- Tumor node metastasis classification of NSCLC patients at diagnosis(At baseline visit)
- Charlson Comorbidity index of NSCLC patients at diagnosis(At baseline visit)
- Proportion of patients who receive radiation by stage at treatment(Approximately 2 years)
- Body Mass Index (BMI) of NSCLC patients at diagnosis(At baseline visit)
- NSCLC clinical subtype of NSCLC patients at diagnosis(At baseline visit)