RecruitingNCT05537922

I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy


Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

2,200 participants

Start Date

Oct 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called I3LUNG) is building a large data platform to better predict which patients with advanced non-small cell lung cancer (NSCLC) will benefit from immunotherapy, and to help personalize treatment decisions. Researchers will collect detailed clinical, genetic, and imaging data from patients receiving immunotherapy to develop smarter prediction tools. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with advanced (stage IIIB/C or IV) non-small cell lung cancer confirmed by biopsy - You have received or are scheduled to start immunotherapy as part of your cancer treatment - Tumor tissue (a preserved biopsy sample) is available for molecular testing - Your general health is adequate (ECOG score 0–2) **You may NOT be eligible if:** - You have early-stage lung cancer - No tumor tissue is available for testing - You are not able or willing to provide consent (for the prospective arm) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

University of Chicago

Chicago, Illinois, United States

Metropolitan Hospital

Athens, Greece

Shaare Zedek Medical Center

Jerusalem, Israel

Vall D'Hebron Institute of Oncology

Barcelona, Spain

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NCT05537922


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