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Recruiting NCT05797493

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

Observational Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atezolizumab.
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Atezolizumab
    Upfront chemo-immunotherapy

Primary outcome measures

  • PFS [Time frame: Up to 60 months]
  • OS [Time frame: Up to 60 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Gemelli IRCCS — Rome

Identifiers

NCT: NCT05797493 · 5061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗