Registry of the National Network Genomic Medicine Lung Cancer (nNGM), Linking Data on Molecular Diagnostics, Clinical Characteristics, Treatment Patterns and Outcomes of Subjects With Non-Small Cell Lung Cancer in Germany
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Registry of the national Network Genomic Medicine Lung Cancer (nNGM), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (NSCLC) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in Germany
详细描述
Within the national Network Genomic Medicine Lung Cancer (nNGM), comprehensive molecular diagnostics and treatment recommendations are provided by 23 certified cancer centres according to standardized procedures for patients with non-resectable NSCLC. More than 400 network partners across Germany (including hospitals and oncological practices) report data on subsequent treatment and outcomes to the nNGM registry. Clinical outcomes are continuously evaluated through analysis of data collected in a decentralized registry. The nNGM registry records the patient journey and course of the disease from first histologically confirmed diagnosis to death or loss to follow-up and comprises detailed data on demographic and clinical characteristics, molecular diagnostics (including comprehensive biomarker testing results), treatments (targeted therapy, immunotherapy, chemotherapy, radiotherapy, best supportive care) and outcomes (overall survival, response, disease progression, time to next treatment). Patients have been actively involved throughout all stages of the design and running of the network and its registry.
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
- •Age ≥ 18 years
- •Histologically confirmed, locally advanced or metastatic NSCLC (Union for International Cancer Control [UICC] stage IIIb/IV; non-resectable NSCLC)
- •From 07/2023: histologically confirmed NSCLC stage Ib, II, III (UICC)
排除标准
- •Missing written informed consent
结局指标
主要结局
overall survival
时间窗: assessed up to 100 months
overall survival (in months)
molecular testing
时间窗: 1 year
descriptive data on results, frequency and methods of molecular testing
treatment patterns
时间窗: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months
descriptive data on systemic treatments (including combination and sequence of treatments)
time to next treatment
时间窗: from start of treatment to the start of the next therapy, death or loss to follow-up, whichever came first, assessed up to 100 months
time to next treatment (in months)
progression free survival
时间窗: from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months
progression free survival (in months)
次要结局
未报告次要终点
研究者
Prof. Dr. Juergen Wolf
Professor Dr. med., Spokesperson of the National Network Genomic Medicine Lung Cancer
University of Cologne