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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT05537922
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Jan 2023
Primary completion
Oct 1, 2025
Completion
Oct 1, 2027

Study Design

Enrollment
2,200 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    This cohort includes the analysis of a multicentric retrospective cohort of more than 2,000 patients. This cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model). All available clinical data will be collected. Also, CT and PET scans will be collected and a first radiomic signature.
  • Arm: Prospective Cohort
    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.

Primary Outcome Measure

Response Rate [ Time Frame: 8 weeks (i.e. first radiological evaluation) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Marina Garassino

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Chicago· Chicago, IL

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