PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Detection of eosinophils in untreated non-small cell lung cancer patients
研究概览
简要总结
This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •o All stages of NSCLC
- •Stage III-IV NSCLC eligible for ICI treatment
- •18 years or older; non pregnant women
- •in stage III-IV: no previous ICI and before ICI (mono- or combination therapy) initiation
- •Signed informed consent
- •Clinical, biological and radiological evaluation at the CHU de Liège for at least 6 months following treatment initiation
排除标准
- •Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors)
- •Inclusion in a clinical study contraindicating the enrolment in the PROTEON study
研究组 & 干预措施
Eosinophil detection
Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
干预措施: blood draw (Diagnostic Test)
Eosinophil detection
Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
干预措施: induced sputum (Diagnostic Test)
Eosinophil detection
Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
干预措施: lung biopsy (Diagnostic Test)
Eosinophil detection
Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
干预措施: bronchoalveolar lavage (Diagnostic Test)
结局指标
主要结局
Detection of eosinophils in untreated non-small cell lung cancer patients
时间窗: Baseline (pre-treatment)
Concentration of eosinophils will be used in various bodily materials as described above.
次要结局
- Prognostic and predictive value of eosinophils in non-small cell lung cancer patients(Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment)
研究者
Anne Sibille
Dr Anne Sibille
Centre Hospitalier Universitaire de Liege