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

NCT05797493 | Recruiting

• 1 other identifier: 5061
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

sclc; immunotherapy

Outcome Measures

Primary Outcomes (2)

• PFS

  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 from treatment start to the date of death from any cause, assessed up to 60 months

  Up to 60 months

Study Arms (1)

ES-SCLC

ES-SCLC receiving upfront chemo-immunotherapy

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Upfront chemo-immunotherapy

ES-SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ES SCLC patients treated with first line chemo-immunotherapy (EP-IO

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Emilio Bria, Prof.

CONTACT

+39 0630156318; emilio.bria@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 4, 2023
• Study Start: October 4, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)