Non Small Cell Lung Cancer Clinical Trial
— LANTERNOfficial title:
Lung Cancer Multi-omics Digital Human Avatars for Integrating Precision Medicine Into Clinical Practice: the LANTERN Study
The goal of this multi-centric observational clinical trial is to to develop accurate predictive models for lung cancer patients, through the creation of Digital Human Avatars using various omics-based variables and integrating well-established clinical factors with "big data" and advanced imaging features The main goals of LANTERN project are: - To develop prevention models for early lung cancer diagnosis; - To set up personalized predictive models for individual-specific treatments; Lung cancer patients will be prospectively enrolled and main omics data (including radiomics and genomics) will be collected, reflecting the main omics domains associated with the lung cancer diagnosis and decision making pathway. An exploratory analysis across all collected datasets will select a pool of potential biomarkers to create a multiple distinct multivariate models, trained though advanced machine learning (ML) and AI techniques sub-divided into specific areas of interest. Finally, the developed predictive models will be validated in order to test their robustness, transferability and generalizability, leading to the development of the Digital Human Avatar.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | June 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with (suspected) NSCLC - Age >18 yrs - ECOG 0-3 - Written Informed Consent Exclusion Criteria: - ECOG 4 - Psychosocial, or emotional conditions controindicating participation to the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Accademia del Paziente Esperto EUPATI, Rome, Italy, Hospital de la Santa creu i Sant Pau - Barcelona, Koc University Hospital, Technische Universität Dresden, University of Debrecen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To develop prevention models for early lung cancer diagnosis | Development of prognostic model in NSCLC patients using omics data. In particular, will be determinate the association between radiomics characteristics and biomarkers to lung cancer stage and survival outcome.
Omics data and prognostic model will be tested in terms of disease free and overall survival comapring the different models. |
36 months |
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