Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
Recruiting · NCT05797493 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- none
Where it is running
1 location listed.
- Fondazione Policlinico Gemelli IRCCS - Rome, Italy