Actively Recruiting

Age: 18Years +
All Genders
NCT05537922

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

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2023-01-06

2200

Participants Needed

4

Research Sites

260 weeks

Total Duration

On this page

Sponsors

F

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead Sponsor

V

Vall d'Hebron Institute of Oncology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
  • Histologically confirmed diagnosis of stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer
  • Received any line of immunotherapy (maintenance therapy with Durvalumab allowed) for retrospective cohort; clinical indication for frontline immunotherapy for prospective cohort
  • Patients with central nervous system metastasis allowed
  • Patients with driver genomic alterations allowed (only for retrospective cohort)
  • Signed informed consent form (only for prospective cohort)
  • Availability of at least one FFPE block for -omics data generation (only for prospective cohort)
Not Eligible

You will not qualify if you...

  • Patients without minimal treatment information data for retrospective cohort
  • Prior treatment for advanced disease (only for prospective cohort)
  • Unable or unwilling to comply with study procedures including quality of life questionnaires

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

2

Metropolitan Hospital

Athens, Greece

Actively Recruiting

3

Shaare Zedek Medical Center

Jerusalem, Israel

Actively Recruiting

4

Vall D'Hebron Institute of Oncology

Barcelona, Spain

Actively Recruiting

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Research Team

A

Arsela Prelaj, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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