NCT05537922Recruiting
I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Source: ClinicalTrials.gov · Last updated 6 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2200 (estimated)
- First submitted
- 5 Sept 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Lung cancer
- NCT number
- NCT05537922
What you commit to
- Study type: Observational
- Planned participants: 2200
- From 1 Oct 2022 to the primary completion date, 1 Oct 2025
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for advanced disease (only for prospective cohort)
Other
- Patients without minimal treatment information data to be included in the retrospective cohort
- Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall d'Hebron Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Metropolitan Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.