NCT05537922 I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
| NCT ID | NCT05537922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,200 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,200 participants in total. It began in 2022-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Age \>/= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. * Histologically confirmed diagnosis of stage IIIB/C-IV Non-Small-Cell Lung Cancer * 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. * Patients with CNS metastasis are allowed * Patients with driver genomic alterations are allowed (only for retrospective cohort) * 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) * Availability of at least one FFPE block for -omics data generation (only for prospective cohort) Exclusion Criteria: * Patients without minimal treatment information data to be included in the retrospective cohort * Prior treatment for advanced disease (only for prospective cohort) * Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05537922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05537922 currently recruiting?
Yes, NCT05537922 is actively recruiting participants. Contact the research team at arsela.prelaj@istitutotumori.mi.it for enrollment information.
Where is the NCT05537922 trial being conducted?
This trial is being conducted at Chicago, United States, Athens, Greece, Jerusalem, Israel, Barcelona, Spain.
Who is sponsoring the NCT05537922 clinical trial?
NCT05537922 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 2,200 participants.
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