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

NCT ID: NCT06372054

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-05

Study Completion Date

2027-02-05

Brief Summary

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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

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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.

Conditions

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Oxidative Injury Stress Physiological Discogenic Pain Cardiovascular Risk Factor Space Maintenance Epigenetic Changes LONGEVITY 1 Neuroplasticity NGS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Biological sample collection

Intervention Type OTHER

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.

Biological sample collection

Intervention Type OTHER

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

Interventions

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Biological sample collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

26 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Italian Air Force

UNKNOWN

Sponsor Role collaborator

A-Tono

UNKNOWN

Sponsor Role collaborator

Ministry of Defense, Italy

UNKNOWN

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Marfia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force

Emanuele Garzia, MD, PhD

Role: STUDY_CHAIR

Italian Air Force

Marco Locatelli, MD, PhD

Role: STUDY_CHAIR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Francesco Vestito, PhD

Role: STUDY_CHAIR

Italian Air Force

Locations

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CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Marfia, MD, PhD

Role: CONTACT

0256660100 ext. +39

Laura Guarnaccia, PhD

Role: CONTACT

0255034268 ext. +39

Facility Contacts

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Stefania E Navone, PhD

Role: primary

0256660100 ext. +39

References

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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.

Reference Type RESULT
PMID: 35678198 (View on PubMed)

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.

Reference Type RESULT
PMID: 36998982 (View on PubMed)

Other Identifiers

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TORNADO

Identifier Type: -

Identifier Source: org_study_id

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