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Trial Title:
Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
NCT ID:
NCT05797493
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Atezolizumab
Conditions: Keywords:
sclc
immunotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Upfront chemo-immunotherapy
Arm group label:
ES-SCLC
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.
Criteria for eligibility:
Study pop:
ES SCLC patients treated with first line chemo-immunotherapy (EP-IO
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. histologically- or cytologically-documented extensive-stage SCLC
2. to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti
PD1/PD-L1 inhibitors
3. No evidence of brain metastases at diagnosis
4. ECOG PS 0-2
5. adult patients (aged ≥ 18 years) at diagnosis;
6. signing of informed consent approved by the local Ethic Committee
Exclusion Criteria:
- none
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Emilio Bria, Professor
Phone:
0630155202
Phone ext:
+39
Email:
emilio.bria@policlinicogemelli.it
Start date:
October 4, 2022
Completion date:
June 2027
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797493
