Clinical trial NCT06372054: TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models
Official title: Integration of Omics-based Technologies and Artificial Intelligence to Identify Predictive Risk Models in a Air Force's Pilot Cohort for the Maintenance of Safety, Well-being, Health, and Performance to be Translated to Civil Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oxidative Injury
Stress Physiological
Discogenic Pain
Cardiovascular Risk Factor
Space Maintenance
Epigenetic Changes
LONGEVITY 1
Neuroplasticity
NGS
Keywords: pilots
air force
epigenetic change
environmental exposure
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Italian Air Force
name: A-Tono
name: Ministry of Defense, Italy
First posted: 2024-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 26
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.

Brief summary: The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.

Detailed description: The high-performance pilots of the Italian Air Force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. However, this environmental exposure may potentially affect human health, well-being and performance.

The study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an Artificial Intelligence algorithm expressly trained to create reliable risk models.

The final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.

Eligibility criteria: Inclusion Criteria:

* Being part of the Italian Air Force, as in active flight service or ground staff
* Age between 26 and 38 years
* Consent to collect biological samples and use the wearable device to monitor exposure parameters

Exclusion Criteria:

* Age \< 25 years and \> 39 years
* no signature on informed consent

Primary outcomes:
measure: Assessment of flight-related exposure data and molecular modifications
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Assessment of General Health
timeFrame: Through study completion, an average of 3 year
measure: Assessment of Sleep Quality
timeFrame: Through study completion, an average of 3 year
measure: Assessment of eating habits
timeFrame: Through study completion, an average of 3 year
measure: Creation of reliable AI and disease-based models for personalized medicine
timeFrame: Through study completion, an average of 3 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy
Study officials:
affiliation: Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force
name: Giovanni Marfia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Italian Air Force
name: Emanuele Garzia, MD, PhD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Marco Locatelli, MD, PhD
role: STUDY_CHAIR
affiliation: Italian Air Force
name: Francesco Vestito, PhD
role: STUDY_CHAIR
References:
citation: Marfia G, Navone SE, Guarnaccia L, Campanella R, Locatelli M, Miozzo M, Perelli P, Della Morte G, Catamo L, Tondo P, Campanella C, Lucertini M, Ciniglio Appiani G, Landolfi A, Garzia E. Space flight and central nervous system: Friends or enemies? Challenges and opportunities for neuroscience and neuro-oncology. J Neurosci Res. 2022 Sep;100(9):1649-1663. doi: 10.1002/jnr.25066. Epub 2022 Jun 9.
citation: Marfia G, Guarnaccia L, Navone SE, Ampollini A, Balsamo M, Benelli F, Gaudino C, Garzia E, Fratocchi C, Di Murro C, Ligarotti GK, Campanella C, Landolfi A, Perelli P, Locatelli M, Ciniglio Appiani G. Microgravity and the intervertebral disc: The impact of space conditions on the biomechanics of the spine. Front Physiol. 2023 Mar 14;14:1124991. doi: 10.3389/fphys.2023.1124991. eCollection 2023.