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

April 16, 2024 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20139
        • Recruiting
        • CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy
        • Sub-Investigator:
          • Stefania E Navone, PhD
        • Sub-Investigator:
          • Laura Guarnaccia, PhD
        • Sub-Investigator:
          • Laura Begani, MSc
        • Contact:
        • Principal Investigator:
          • Giovanni Marfia, MD, PhD
        • Sub-Investigator:
          • Monica R Miozzo, PhD
        • Sub-Investigator:
          • Orazio Granato, PhD
        • Sub-Investigator:
          • Silvana Pileggi, PhD
        • Sub-Investigator:
          • Luisella Vigna, MD, PhD
        • Sub-Investigator:
          • Matteo Bonzini, MD, PhD
        • Sub-Investigator:
          • Laura Fontana, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-performance Italian Air Force Pilots

The primary study cohort is represented by "super-healthy" high-performance Italian Air Force Pilots, aged between 26 and 38 years, in active flight service.

Intervention: not applicable
Other: Biological sample collection
Collection of biological samples (blood, urine, saliva) and clinical data
Italian Air Force ground staff
This cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort.
Other: Biological sample collection
Collection of biological samples (blood, urine, saliva) and clinical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of flight-related exposure data and molecular modifications
Time Frame: Through study completion, an average of 3 year
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
Through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of General Health
Time Frame: Through study completion, an average of 3 year
Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)
Through study completion, an average of 3 year
Assessment of Sleep Quality
Time Frame: Through study completion, an average of 3 year
Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
Through study completion, an average of 3 year
Assessment of eating habits
Time Frame: Through study completion, an average of 3 year
Recording of eating habits by Food Frequency Questionnaire (EPIC)
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
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
Through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

University of Milan
Italian Air Force
A-Tono
Ministry of Defense, Italy

Investigators

  • Principal Investigator: Giovanni Marfia, MD, PhD, Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force
  • Study Chair: Emanuele Garzia, MD, PhD, Italian Air Force
  • Study Chair: Marco Locatelli, MD, PhD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Study Chair: Francesco Vestito, PhD, Italian Air Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

February 5, 2025

Study Completion (Estimated)

February 5, 2027

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TORNADO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Subject's data will be collected in completely anonymized form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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