Trial Title:
APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
NCT ID:
NCT05550961
Condition:
NSCLC
Cancer
Lung Cancer
Adenocarcinoma of Lung
Squamous Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Adenocarcinoma of Lung
Conditions: Keywords:
#NSCLC
#Immunotherapy
#Targeted Therapy
#Artificial Intelligence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Summary:
APOLLO 11 main aim is to build a strong Italian long-lasting lung cancer network (in
around 48 Italian centres) on real world data and translational research by creating a
decentralized long-term national database (settle locally in each centre) and a "virtual"
multilevel biobank in each centre. Besides, APOLLO 11 will take advantage of the
translational research joint effort with the credo "unity is strength".
Detailed description:
With the advent of several innovative therapies ("target" therapies, immunotherapy (IO)
and/or next generation therapies), the identification of prognostic/predictive and/or
resistance biomarkers represents the main goals of translational research in advanced
lung cancer (aLC). In particular, with the arrival of IO the treatment landscape of
advanced Non-Small Cell Lung Cancer (NSCLC) patients (pts), have radically changed
prolonging significantly the overall survival (OS). The role of Programmed Death Ligand 1
(PD-L1) remains undefined and to date no other biomarker are used to select patients for
IO. Artificial Intelligence (AI) frameworks, which synthesize and correlate information
from different data sources, is a potentially highly efficient instrument to construct
algorithms reinforcing the individualized prediction.
APOLLO 11 main aim is to build a strong Italian long-lasting lung cancer network (in
around 48 Italian centres) on real world data and translational research by creating a
decentralized long-term national database and a "virtual" multilevel biobank. This will
allow to avoid worthless dispersion of single institution data, which often remaine
unused and inconclusive due to limited number of patients and low statistical power.
Besides, APOLLO 11 will take advantage of the translational research joint effort with
the credo "unity is strength". The multilevel structure is designed also for smallest
centres of give them possibility to contribute to biobank looking at their internal
facilities.
APOLLO 11 have the goal to establish the consortium by fully activating at least 20 of
the 48 involved centres able to collect data within the database and to guarantee the
activation ready for at least 10 biobanks able to collect samples (tumour tissue, blood,
stool and urine). Moreover, the key scientific aim of the project is to provide answers
about aNSCLC pts treated with IO. In particular, try to find a "software" biomarker able
to better predict IO selection compare to standard of care single biomarker (e.g., PD-L1,
TMB) using artificial intelligence/machine/deep learning (AI/DL/ML) methodologies. Real
world (demographic, histology, PD-L1, molecular, treatment and outcomes information etc),
radiomics and where available (from previous researches) multiomic data from all the
activated centres will be collected. Furthermore, single-cell RNA sequencing (scRNA seq)
analysis will be carry out. Finally, AI/ML/DL will be used to integrate the multisource
data, analyse them and develop predictive algorithms of IO efficacy in NSCLC pts.
Explainable trustworthy AI (XAI) methodology will be used in order to better understand
black box for explaining clinical and biological insight.
Criteria for eligibility:
Study pop:
Patients with NSCLC treated with innovative therapies in different Italian Centers will
be enrolled in retrospective and prospective cohorts.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Provision of signed and dated written informed consent, when applicable, by the
patient or legally acceptable representative prior to any mandatory study-specific
procedures, sampling, and analyses;
2. Patients must be ≥18 years of age at the time of signing the informed consent;
3. Histologically or cytologically confirmed lung cancer (NSCLC or SCLC) at any stage
(I-IV) candidate to receive or already treated with innovative therapies (ICIs,
target therapies and next generation therapies).
Exclusion Criteria:
1. Patients who are or will be taking other unapproved antineoplastic therapies
concurrently are not eligible.
2. Patients who have not received an oncological systemic innovative therapy at any
setting
3. Patients received only local treatments (e.g., only surgery, or only radiotherapy)
4. Patients who received only standard chemotherapy are excluded.
5. Patients who received treatment therapies before 2010 are excluded.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Arsela Prelaj, MD
Start date:
October 1, 2022
Completion date:
October 1, 2032
Lead sponsor:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Collaborator:
Agency:
Politecnico di Milano
Agency class:
Other
Collaborator:
Agency:
Ospedale Policlinico San Martino
Agency class:
Other
Collaborator:
Agency:
Insieme per i Pazienti di Oncologia Polmonare Onlus (IPOP)
Agency class:
Other
Collaborator:
Agency:
ASST Grande Ospedale Metropolitano Niguarda
Agency class:
Other
Collaborator:
Agency:
University of Campania "Luigi Vanvitelli"
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera dei Colli
Agency class:
Other
Collaborator:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera S. Maria della Misericordia
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera "Sant'Andrea"
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Agency class:
Other
Collaborator:
Agency:
IRCCS Sacro Cuore Don Calabria di Negrar
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Agency class:
Other
Collaborator:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Collaborator:
Agency:
Azienda Unità Sanitaria Locale della Romagna
Agency class:
Other
Collaborator:
Agency:
Istituti Ospitalieri di Cremona
Agency class:
Other
Source:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05550961
https://www.associazione-ipop.org/progetto-apollo11/
