Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer (PICASSO)
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.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: EMILIO BRIA, Prof.
- Phone Number: +39 0630156318
- Email: emilio.bria@policlinicogemelli.it
Study Locations
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-
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Rome, Italy, 00168
- Recruiting
- Fondazione Policlinico Gemelli IRCCS
-
Contact:
- Emilio Bria, Professor
- Phone Number: +39 0630155202
- Email: emilio.bria@policlinicogemelli.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ES-SCLC
ES-SCLC receiving upfront chemo-immunotherapy
|
Upfront chemo-immunotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS
Time Frame: 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
|
Up to 60 months
|
|
OS
Time Frame: Up to 60 months
|
Time from treatment start to the date of death from any cause, assessed up to 60 months
|
Up to 60 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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