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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Emilio Bria, Professor

CONTACT

[email protected]

0630155202 ext. +39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

Upfront chemo-immunotherapy

Primary outcomes

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
OS

Time frame: Up to 60 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilio Bria, Prof.

CONTACT

[email protected]

+39 0630156318

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: PICASSO

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Apr 4, 2023
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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