Lung Cancer Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Treatment frequency
研究概览
简要总结
Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.
This malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.
Despite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.
详细描述
This registry is designed as multicenter observational cohort of patients with lung cancer. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.
A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.
Data will be collected from all sites willing to participate.
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
- •stage III A-C and IV A-B NSCLC
- •limited disease (LD) and extensive disease (ED) SCLC)
- •patients ≥ 18 years
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
Treatment frequency
时间窗: 10 years
To describe frequency of treatment
General characteristics
时间窗: 10 years
To describe the general characteristics of advanced or metastatic stage patients in Austria (Stage III A-C and IV A-B NSCLC, limited disease (LD) and extensive disease (ED) SCLC)
Molecular testing
时间窗: 10 years
To describe molecular testing in patients with advanced or metastatic lung cancer * number of patients with molecular testing * methods for molecular testing * number of patients with PD-L1 testing * PD-L1 % range per disease stage * PD-L1 test antibody used * number of genes tested * number of patients with at least one mutation identified * number of patients with at least one druggable target identified
Characterize subgroups
时间窗: 10 years
To describe and characterize subgroups * Number of patients with NSCLC * Number of patients that receive immune-checkpoint inhibitors * Number of patients with targetable/druggable mutations
Treatment duration
时间窗: 10 years
To describe duration of treatment
Toxicity of treatment
时间窗: 10 years
To describe number of patients with toxicity of treatment with a focus on immune related adverse events
Degree of treatment response
时间窗: 10 years
To describe degree of treatment response in %
Treatment sequence
时间窗: 10 years
To describe sequence of use of various treatments
Outcome OS
时间窗: 10 years
To describe patient outcome by means of overall survival (OS) in %
Outcome PFS
时间窗: 10 years
To describe patient outcome by means of progression free survival (PFS) in %
次要结局
未报告次要终点