A Prospective Epidemiologic and Clinical Feature Study of Non-Small Cell Lung Cancer (NSCLC) Patients With ALK Positive in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,649
- 试验地点
- 2
- 主要终点
- the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer
研究概览
简要总结
This is a post-marketing, observational, non-interventional, multi-central study of patients with non-small cell lung cancer (NSCLC), with data collected prospectively from medical records at inclusion. The primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase (ALK)-positive in unselected Chinese patients with NSCLC.
详细描述
Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology. ALK positive status will be detected by Ventana immunohistochemistry (IHC) (Ventana Medical Systems, Inc. and Roche Diagnostics International, Inc). When ALK positive patients are detected, crizotinib will be administrated by various solutions based on physician's desecration and patients' willingness.
The secondary objectives include: 1.To obtain the epidemiologic data of ALK positive in unselected Chinese patients with NSCLC.2.To describe demographic, socioeconomic [such as age, gender, race/ethnicity, geographic location (including rural/urban area), pathologic parameters, education, family income, National Reimbursement Drug List (NRDL) or Provincial Reimbursement List (PRDL)], and clinical characteristics of NSCLC patients with ALK positive.
The exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (≥18 years), both sex.
- •Histologically or cytologically proven diagnosis of primary NSCLC, including squamous cell carcinoma and adenocarcinoma.
- •Written informed consent.
排除标准
- •Those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (SCLC) or metastatic disease from other organs.
结局指标
主要结局
the frequency of ALK rearrangement in unselected Chinese patients with non-small cell lung cancer
时间窗: one and half years
次要结局
- demographic, socioeconomic,clinical and pathological features of ALK-positive NSCLC patients(one and half years)