Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,400
- 试验地点
- 1
- 主要终点
- changes during the project
研究概览
简要总结
Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany
详细描述
Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.
PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.
Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.
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
- •Patients who meet all of the following criteria are eligible for the project:
- •Age ≥ 18 years
- •Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
- •Main project (Metatstatic NSCLC):
- •Confirmed non-small cell lung cancer (NSCLC)
- •Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only"
- •Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
- •Systemic therapy or best supportive care
- •Satellite Stage I/II/III (NSCLC):
- •Confirmed non-small cell lung cancer (NSCLC)
- •Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
- •Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)
- •Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care
- •Satellite SCLC
- •Confirmed Small cell lung cancer (SCLC)
- •Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
- •Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care
排除标准
- 未提供
结局指标
主要结局
changes during the project
时间窗: 3 years
To investigate changes in diagnostics, treatment or outcome during the course of the project
supportive therapies
时间窗: 3 years
to collect key data on specific supportive therapies
progression free survival
时间窗: 3 years
To assess effectiveness of systemic treatments in regards to progression free survival.
biomarker
时间窗: 3 years
To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment
Response rate
时间窗: 3 years
To assess effectiveness of systemic treatments in regards to response rate.
physician-reported factors
时间窗: 3 years
To describe physician-reported factors affecting treatment decision making besides biomarker profiling
physical and psychological well-being patient-reported outcomes
时间窗: 3 years
To evaluate patient-reported outcomes concerning physical and psychological well-being.
treatment
时间窗: 3 years
To describe systemic treatments and sequential treatments applied in real-life practice
overall survival
时间窗: 3 years
To assess effectiveness of systemic treatments in regards overall survival.
general health-related and individual quality of life (QoL) patient-reported outcomes
时间窗: 3 years
To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication
anxiety patient-reported outcomes
时间窗: 3 years
To evaluate patient-reported outcomes concerning anxiety.
次要结局
未报告次要终点