TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age26-38
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 25 years and > 39 years

no signature on informed consent

Trial population

The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biological sample collection

    Other intervention

    Collection of biological samples (blood, urine, saliva) and clinical data

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: High-performance Italian Air Force Pilots1 intervention
Group B: Italian Air Force ground staff1 intervention

Trial outcomes

Primary outcomes

1

Assessment of flight-related exposure data and molecular modifications

Collection of information on: i) lifestyle, ii) medical examination, iii) previous trauma, iv) cumulative professional exposure to flying, determination of panel of genes and circulating markers to assess prognostic and predictive factors

Time frame
Through study completion, an average of 3 year

Secondary outcomes

1

Assessment of General Health

Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)

Time frame
Through study completion, an average of 3 year
2

Assessment of Sleep Quality

Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)

Time frame
Through study completion, an average of 3 year
3

Assessment of eating habits

Recording of eating habits by Food Frequency Questionnaire (EPIC)

Time frame
Through study completion, an average of 3 year
4

Creation of reliable AI and disease-based models for personalized medicine

Integration of information obtained from anamnesis, questionnaires, biochemical, genomic, epigenomic, proteomic data with the measurement of heart rate, oxygenation, acceleration, external temperature, presence of ultrasound, infrasound and radiation with artificial intelligence algorithm for the creation of reliable models of disease based on personalized medicine

Time frame
Through study completion, an average of 3 year

Other outcomes

Sponsors and contacts

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead sponsor

University of Milan

Collaborator

Italian Air Force

Collaborator

A-Tono

Collaborator

Ministry of Defense, Italy

Collaborator