RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05537922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>/= 18 years.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
  3. * Histologically confirmed diagnosis of stage IIIB/C-IV Non-Small-Cell Lung Cancer
  4. * Received any line immunotherapy (maintenance therapy with Durvalumab is allowed) for retrospective cohort; clinical indication for frontline treatment with immunotherapy as first line treatment for prospective cohort.
  5. * Patients with CNS metastasis are allowed
  6. * Patients with driver genomic alterations are allowed (only for retrospective cohort)
  7. * Evidence of a personally signed and dated ICF indicating that the patient has been informed of and understands all pertinent aspects of the study before enrolment (only for prospective cohort)
  8. * Availability of at least one FFPE block for -omics data generation (only for prospective cohort)
  1. * Patients without minimal treatment information data to be included in the retrospective cohort
  2. * Prior treatment for advanced disease (only for prospective cohort)
  3. * Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires

Contacts and Locations

Study Contact

Arsela Prelaj, MD
CONTACT
+39 022390 3647
arsela.prelaj@istitutotumori.mi.it

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • Artificial Intelligence
  • Immunotherapy

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer
  • Lung Cancer Metastatic
  • Lung Cancer, Nonsmall Cell
  • Lung Adenocarcinoma