TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological sample collection.
- Who it may be relevant to
- Registry conditions: Oxidative Injury, Stress Physiological, Discogenic Pain, Cardiovascular Risk Factor. Basic parameters: 26 years — 38 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Biological sample collection
Collection of biological samples (blood, urine, saliva) and clinical data
Primary outcome measures
- Assessment of flight-related exposure data and molecular modifications [Time frame: Through study completion, an average of 3 year]
Secondary outcome measures (4)
- Assessment of General Health [Time frame: Through study completion, an average of 3 year]
- Assessment of Sleep Quality [Time frame: Through study completion, an average of 3 year]
- Assessment of eating habits [Time frame: Through study completion, an average of 3 year]
- Creation of reliable AI and disease-based models for personalized medicine [Time frame: Through study completion, an average of 3 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy — Milan
Publications
- 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. PMID 35678198
- 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. PMID 36998982
Identifiers
NCT: NCT06372054 · TORNADO