Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
The scope of the PICASSO project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements.
The PICASSO project is aimed to validate in real world population the predictive role of SCLC transcriptomic classification (particularly, I-SCLC subtype) and to explore correlations with dynamic changes in peripheral blood immunity. Additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.
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
- •histologically- or cytologically-documented extensive-stage SCLC
- •to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors
- •No evidence of brain metastases at diagnosis
- •ECOG PS 0-2
- •adult patients (aged ≥ 18 years) at diagnosis;
- •signing of informed consent approved by the local Ethic Committee
排除标准
- 未提供
研究组 & 干预措施
ES-SCLC
ES-SCLC receiving upfront chemo-immunotherapy
干预措施: Atezolizumab (Drug)
结局指标
主要结局
OS
时间窗: Up to 60 months
Time from treatment start to the date of death from any cause, assessed up to 60 months
PFS
时间窗: Up to 60 months
Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
次要结局
未报告次要终点
研究者
Bria Emilio
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS