RecruitingNCT05797493

Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

100 participants

Start Date

Oct 4, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

  • none

Interventions

DRUGAtezolizumab

Upfront chemo-immunotherapy


Locations(1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy

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NCT05797493


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